OBWEGESER CURVED DOWN 12MM X 55MM 24,0CM

OBWEGESER RETRACTOR • DOWNWARDS CURVED • 12x55MM • 24.0 CM • CE CLASS I • ISO 13485:2016

Broad Tall Retractor for Demanding Exposure in Temporomandibular Joint and Mandibular Surgery

The OBWEGESER Retractor downwards curved, 12x55mm, 24.0 cm is a Class I medical device according to ISO 13485:2016. This exceptionally dimensioned variant with a wide (12 mm) and very tall (55 mm) tip is a specialized instrument for complex procedures in oral and maxillofacial surgery (OMFS). It enables powerful and stable retraction of larger soft tissue masses at depth.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I (Regulation (EU) 2017/745)
✔ OBWEGESER special design with wide, tall, and downwards curved tip
✔ Wide and very tall blade (12x55 mm) for stable surface retraction at depth
✔ High-grade stainless steel 1.4401/316L – corrosion-resistant and biocompatible
✔ Biocompatibility tested according to ISO 10993
✔ Atraumatic, carefully rounded edges
✔ Optimal length of 24.0 cm for excellent leverage and control
✔ Autoclavable and reusable

Advantages of the OBWEGESER Retractor (12x55mm, downwards curved):

• Stable Retraction of Large Soft Tissue Volumes: The combination of width and height allows for secure holding of extensive tissue areas (e.g., entire cheek, masticatory muscles) for an optimal view of deep-seated structures like the mandibular ramus or the temporomandibular joint.
• Optimal Exposure for Complex Procedures: Indispensable for extensive tumor resections in the floor of mouth/cheek region, major reconstructive procedures on the mandible, or difficult revision surgeries of the TMJ.
• Reduced Risk of Tissue Trauma: The broad surface distributes retraction pressure evenly and minimizes point pressure damage in sensitive facial tissue.
• Specialized for Access to the Infratemporal Fossa: Enables controlled retraction of the temporalis muscle or other deep muscles for procedures in the posterior maxillary and infratemporal region.
• Professional Control in Difficult Anatomies: Provides surgeons with stable and precise control even in obese patients or those with pronounced musculature.

Technical Specifications:

• Model: OBWEGESER Retractor, downwards curved (Broad-Tall Variant)
• Type: Specialized hook for OMFS with wide, tall, and inferiorly curved tip
• Blade Dimensions: Approx. 12 mm (width) x 55 mm (height)
• Total Length: 24.0 cm
• Blade Shape: Wide, very tall blade with defined downward curvature
• Material: Surgical Stainless Steel 1.4401 / 316L
• Surface: High-gloss polished
• Processing: Autoklavable up to 135°C, suitable for repeated reprocessing
• Special Feature: High-performance instrument for demanding exposure in complex OMFS
• Risk Class: I according to Regulation (EU) 2017/745 (MDR)

Fields of Application (Specialized):

• Extensive tumor resections in the oral and maxillofacial region with subsequent microvascular reconstruction
• Complex midface and mandibular traumatology with comminuted fractures
• Revision temporomandibular joint surgery for ankylosis or severe osteoarthritis
• Orthognathic surgery for severe dysgnathia with large movement distances
• Removal of large odontogenic tumors or cysts in the mandibular angle/ramus region
• Approaches to the infratemporal fossa and pterygopalatine fossa

Important Application Notes:

• FOR USE BY HIGHLY EXPERIENCED OMFS SURGEONS IN MAXIMUM CARE CENTERS ONLY.
• HEAVY PRECISION INSTRUMENT WITH SIGNIFICANT LEVERAGE. Improper use can lead to severe nerve or vascular injuries.
• Prerequisite: Before each use, perfect structural integrity and correct curvature must be verified. Bending of the large tip renders the instrument unusable.
• Extreme caution is required near the facial nerve, branches of the trigeminal nerve, and vessels of the maxillary artery.
• The instrument is for soft tissue retraction only. Under no circumstances use as a lever or clamp for bony structures.
• Due to its size, careful manual cleaning of the blade surface and edges is required before automated reprocessing.
• Discard immediately at the slightest signs of material fatigue, bending, or polish damage and do not have it repaired.