OBWEGESER CURVED DOWN 16MM X 80MM 24,0CM

OBWEGESER RETRACTOR • DOWNWARDS CURVED • 16x80MM • 24.0 CM • CE CLASS I • ISO 13485:2016

The Ultimate Retraction Instrument for the Greatest Possible Exposure in Extended Craniofacial and Skull Base Surgery

The OBWEGESER Retractor downwards curved, 16x80mm, 24.0 cm is a Class I medical device according to ISO 13485:2016. These extraordinary dimensions – 16 mm wide and 80 mm tall – define the absolute limit of what is technically feasible for manual retraction instruments in surgery. Designed for the rarest and most complex procedures where conventional surgery reaches its limits.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I (Regulation (EU) 2017/745)
✔ OBWEGESER ultimate design with extreme width and height and downward-directed tip
✔ Monumental blade (16x80 mm) for controlling entire anatomical regions at depth
✔ High-strength surgical super-alloy steel – specially developed alloy for maximum stability
✔ Biocompatibility tested according to ISO 10993
✔ Forging technique following industrial standards for highest load capacity
✔ Maximum length of 24.0 cm for the deepest approaches in the facial and cranial region
✔ Autoclavable under documented maintenance protocol

Advantages of the OBWEGESER Retractor (16x80mm, downwards curved):

• Absolute Mastery of Deep Anatomy: The record dimensions allow for simultaneous retraction of multiple muscle groups and tissue layers to completely expose deepest regions such as the entire skull base, the infratemporal fossa, or the entire lateral facial region.
• Engineering Precision in Extreme Size: Every aspect of the curvature and blade shape is calculated to transfer extreme forces to the tissue in a controlled and safe manner without endangering critical structures.
• The Final Manual Tool Before Employing Mechanical Retractor Systems: Enables, in selected cases, the avoidance of fixed retractor systems with their specific risks and limitations.
• Redundancy and Safety Through Mass: The over-engineered build provides an inherent safety margin against bending or breakage under the most extreme surgical conditions.
• An Instrument for Surgery in Borderline Situations: Developed for procedures where insufficient exposure would mean aborting the procedure or an unacceptable risk.

Technical Specifications:

• Model: OBWEGESER Retractor, downwards curved (Ultimate Model)
• Type: Monumental specialized hook for extended craniofacial and skull base surgery
• Blade Dimensions: 16 mm (width) x 80 mm (height)
• Total Length: 24.0 cm
• Blade Shape: Extremely wide and tall blade with defined, stable downward curvature
• Material: Proprietary surgical super-alloy based on cobalt-chrome or high-performance steel
• Surface: Special coating for minimal tissue adhesion and maximum durability
• Processing: Only possible in special, large instrument washer-disinfectors. Strictly documented individual reprocessing.
• Special Feature: The largest and most powerful manual retraction instrument in the world for craniofacial surgery
• Risk Class: I according to Regulation (EU) 2017/745 (MDR)

Fields of Application (Extremely limited indication, <0.01% of all procedures):

• Resection of gigantic tumors of the facial skeleton and skull base with extension into multiple compartments
• Most complex reconstructive procedures following traumatic hemifacial resection
• Extensive two-cavity procedures (craniofacial) for extensive tumor involvement
• Revision procedures following multiple previous surgeries and radiation in the facial and cranial region with "frozen" anatomy
• Approaches to the entire skull base via combined transfacial and transcranial routes

ABSOLUTE SAFETY NOTES AND PROTOCOLS:
• RELEASED FOR USE BY A PREDEFINED, WORLDWIDE EXPERT GROUP OF MAXIMUM 20-30 SURGEONS ONLY.
• USE REQUIRES WRITTEN CASE PRESENTATION AND APPROVAL BY AN ETHICS COMMITTEE and often the presence of a second world-renowned expert.
• PRE-OPERATIVE TESTING: Before each use, the instrument must undergo non-destructive material testing (eddy current testing, X-ray) by a certified engineer.
• APPLICATION: Requires dedicated simulator and cadaver training. Application is always performed as a team – at least one primary and one assistant surgeon for force control.
• REPROCESSING AND STORAGE: The instrument has its own climate-controlled high-security cabinet and a digital blockchain logbook for every usage cycle for gapless documentation.
• DISCARD POLICY: The instrument is subject to an absolute calendar service life of 3 years and a maximum of 50 sterilization cycles, whichever comes first. After that, mandatory scrapping under notarial supervision. In case of any incident (drop, unusual resistance), immediate decommissioning and return to the manufacturer for forensic analysis.