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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 4H/RIGHT/86MM PLATE,FIXATION,BONE

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SYNTHES GMBH 2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 4H/RIGHT/86MM PLATE,FIXATION,BONE Back to Search Results
Catalog Number 04.112.138
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative

Additional procode: hwc. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. 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 (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent revision surgery due to hypersensitivity. The original ankle fracture surgery was performed a year prior. The surgeon reported the patient experienced hypersensitivity and possible metallosis where the plate was placed postoperatively. The implant was extracted successfully and no metallosis was observed. There was no surgical delay. The procedure was successfully completed. This report is for one (1) 2. 7mm/3. 5mm ti lcp lat distal fibula plate 4h/right/86mm. This is report 1 of 4 for (b)(4).

 
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Brand Name2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 4H/RIGHT/86MM
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12392574
MDR Text Key268964317
Report Number8030965-2021-07373
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeCS
PMA/PMN NumberK083213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/02/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number04.112.138
Device LOT Number24P9080
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 Received09/02/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/11/2019
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: 08/31/2021 Patient Sequence Number: 1
Treatment
CORTEX SCREW Ø 3.5 MM, SELF-TAPPING, LEN; CORTSCR Ø3.5 SELF-TAP L14 TI; CORTSCR Ø3.5 SELF-TAP L16 TI
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