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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abscess (1690); 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. (b)(4).
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 reported (b)(6) year-old patient who had oral wound dehiscence with sinus abscess that was treated by wound irrigation and sinus mucosa stripping. This report is for an unknown synthes synpor implants. This report is 3 of 4 for (b)(4).
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Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
MDR Report Key8864605
MDR Text Key153426614
Report Number8030965-2019-66873
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
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
Date FDA Received08/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/06/2019 Patient Sequence Number: 1