MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; MESH, SURGICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoesthesia (2352); No Code Available (3191)

Event Date 09/23/2016

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: this report complaint not be completed; no conclusion could be drawn at the time of filing this report.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, the investigation will be updated as applicable.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.

Event Description

Device report from synthes reports an event in korea, south as follows: this report is being filed after the review of the following journal article: chung, j.H.(2016), transconjunctival incision with lateral paracanthal extension for corrective osteotomy of malunioned zygoma, archives of craniofacial surgery, vol.17 (3), pages 119-127 (korea, south).The aim of this retrospective study is to evaluate outcomes following the zygomaticofrontal suture osteotomy technique using transconjunctival incision with lateral paracanthal extension in patients who underwent correction of malunioned zygoma.Between june 2009 to september 2015, a total of 14 patients (8 males and 6 females) with a mean age of 48 years (range, 28¿69 years), were included in the study.If the zygomatic repositioning created an inferior orbit wall defect or the orbit had been widened by the previous fracture, the orbit is reconstructed using titanium reinforced polyethylene mesh (synpor, depuy synthes inc., warsaw, in, usa).The mean interval from injury to operation was 16 months (range, 12 months to 4 years), and the mean follow-up was 1 year (range, 4 months to 3 years).The following complications were reported as follows: (the article did not indicate which patient were implanted with synthes device).A (b)(6) year-old male patient experienced oral wound dehiscence with sinus abscess that was treated by wound irrigation and sinus mucosa stripping.2 of 6 patients who received nerve decompression, still experienced numbness after 1 year.These impacted products capture the following adverse event: numbness after 1 year.This report is 4 of 4 for (b)(4).This report is for an unknown synthes synpor.

• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8864611
• MDR Text Key: 153393883
• Report Number: 8030965-2019-66877
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 08/06/2019
• 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