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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - PLATES: LCP MEDIAL DISTAL TIBIAL PLATE PLATE,FIXATION,BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Unspecified Infection (1930); Non-union Bone Fracture (2369); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown plates: lcp medial distal tibial plate/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. 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: villamil gallego et al (2015) fractures of the distal tibia treated with angular stability plates. Retrospective observational study of open and minimally invasive techniques, rev pie tobillo. Volume 29(1): pages 11-16 (spain). This retrospective study aims to provide a retrospective analysis of fractures of the proximal third of the intra-articular distal tibia, classified according to the ao as 43b and 43c, treated with angular stable plates. A comparison is made of the outcome of open versus minimally invasive techniques. Between june 2000 and june 2012, 21 patients (6 females, 15 males) with a mean age of 49 years (22-77) diagnosed with fractures of the distal end of the tibia were retrospectively reviewed and analyzed. Patients were treated surgically with angular stable plates, namely lcp medial distal tibial plate, depuy synthes companies of johnson and johnson, and with a follow-up equal to or greater than 12 months. 5 patients underwent minimally invasive technique and 16 underwent open technique. Mean follow-up was 27 months. The following complications were reported as follows: initial complications of the minimally invasive technique: superficial infection 2 patients. Skin necrosis 2 patients. Blisters 1 patient. Reintervention 1 patient. Minimally invasive technique late complications: post-traumatic osteoarthritis 2 patients. Residual pain 2 patients. Reintervention 2 patients. Osteomyelitis 1 patient. Initial complications open technique: blisters 5 patients. Skin necrosis 4 patients. Superficial infection 2 patients. Reintervention 2 patients. Late complications open technique: pain 4 patients. Pseudarthrosis 3 patients. Reintervention 3 patients. Vicious consolidation 1 patient. Post-traumatic osteoarthritis 1 patients. This report is for an unknown synthes angular stable plates, namely lcp medial distal tibial plate.

 
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Brand NameUNK - PLATES: LCP MEDIAL DISTAL TIBIAL PLATE
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 Key12365934
MDR Text Key268081491
Report Number8030965-2021-07182
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2021
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 Received07/28/2021
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: 08/25/2021 Patient Sequence Number: 1
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