MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - RESORBABLE IMPLANTS; SURGICAL MESH

Device Problem No Apparent Adverse Event (3189)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown absorbable mesh (rapidsorb)/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: kim, h.S., kim, s.E., evans, g., and park, s.H.(2012), the usability of the upper eyelid crease approach for correction of medial orbital wall blowout fracture, plastic and reconstructive surgery, vol 130(4), pages 898-905 (usa).The aim of this study was to overcome the problems of other surgical approaches, they proposed an eyelid crease approach through the medial one-third of the lid crease and a 2- to 3-mm superomedial extension incision as a consistent way of reconstruction moderate or severe blowout fractures of the medial orbital wall and investigating the usefulness of this approach.From april of 2009 to march of 2011, a total of 22 patients (17 males and 5 females) with a mean age of 33.9 years (range 9-56 years) underwent reconstruction using a titanium mesh and a porous polyethylene sheet from our competitor's and an unknown synthes absorbable mesh (rapidsorb).Follow-up was 8 to 28 months with an average of 18.3 months.The following complications were reported as follows: 2 patients had revisions in the initial cases where the posterior part of the implant protruded into the orbital cavity and the superior edge was located lateral to the superior oblique muscle.2 patients complained of diplopia on lateral gaze for 6 months, which improved with time.2 patients who had medial and inferior orbital wall fracture developed mild enophthalmos (<1 mm).2 patients developed mild hypertrophic scar at the junction of upper lid crease and superomedial extension incision, but improved in 6 months with conservative management.Patient 2 had a revision surgery.This is for an unknown synthes absorbable mesh (rapidsorb).This is report 1 of 2 for (b)(4).

• Brand Name: UNK - RESORBABLE IMPLANTS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8784821
• MDR Text Key: 150836186
• Report Number: 8030965-2019-66198
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention