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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LCP DISTAL TIBIA PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - PLATES: LCP DISTAL TIBIA PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

Pma/510k: this report is for an unk - plates: lcp distal tibia/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). 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. 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

This report is being filed after the review of the following journal article: chung h-j, choo jw (2013), clinical outcomes of combinations of locking compression plate fixation through minimally invasive percutaneous plate osteosynthesis and interfragmentary screw fixation in distal tibia fractures, j korean foot ankle soc, volume 17, number 2, pages 136-142, (south korea). The purpose of this study is to analyze the outcome of distal tibia fracture treated with the distal tibia lcp with combination of interfragmentary screw. Between january 2008 and march 2012, 34 patients with fracture of distal tibia and underwent minimally invasive fixation using an unknown synthes distal tibia locking compression plate with or without combination of interfragmentary screws were included in the study. There were 17 males and 17 females with a mean age of 51. 8 years (range, 18-77 years). Only locking compression plate fixation was performed in 22 cases, and interfragmentary lag screw fixation was additionally performed in 12 cases. As for the fixation, conventional screws and locking screws were used to fix the proximal area and distal area respectively. If sufficient reduction was not obtained even after manual reduction, an additional minimal incision was made to fix the bone fragments using interfragmentary screws. While fixing the lag screw, (1) unknown synthes 3. 5 mm cortical screw was used in all cases, and it was fixed before the plate was completely locked. Non-weight-bearing lower extremity plaster was suggested for a minimum of 2 weeks after surgery. After that, the plaster was removed, orthosis was put on, gradually joint movements were initiated, and finally partial weight bearing started in 6 weeks after the operation. Radiological tests were performed periodically at intervals of 4 weeks until full weight bearing was possible until 24 weeks, and the final follow-up was performed after 1 year. Complications were reported as follows: 2 patients had tibial-fibular synostosis. 1 patient had peroneal nerve irritation. 1 patient had screw breakage. Plate and screw removal were performed. 12 patients had irritation due to the protrusion of the plate which recovered gradually after osseointegration was achieved and the plate was removed. This report is for the unknown synthes distal tibia locking compression plate and screws. This report is for one (1) unk - plates: lcp distal tibia. This is report 5 of 5 for complaint (b)(4).

 
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Brand NameUNK - PLATES: LCP DISTAL TIBIA
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12380619
MDR Text Key268692663
Report Number8030965-2021-07330
Device Sequence Number1
Product Code HRS
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
Type of Report Initial
Report Date 07/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/27/2021 Patient Sequence Number: 1
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