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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION ,BONE   

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SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION ,BONE    Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Post Operative Wound Infection (2446); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative

There are multiple patients all information is provided in the article. This report is for an unknown construct: plate/ screws/ unknown lot. Part and lot number 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: zyskowski, m. Et al. (2021), is early full weight bearing safe following locking plate orif of distal fibula fractures? bmc musculoskeletal disorders, vol. 22, number 159, pages 1-10 (germany). The aim of the study was to analyze whether orif of ankle fractures using either a standard semitubular plate or a new polyaxial locking plate system result in a better clinical outcome. A total of 45 patients with a mean age of 42 years (range 22¿64 years) were divided into 2 groups; group 1 had 25 patients which were treated with a non-locking (depuy synthes® one-third semitubular plate; depuy synthes®, umkirch, germany) and group 2 had 20 patients which were treated with a locking (newclip technics® active ankle system 2,8/3,5 mm, pa de la lande saint martin, france). The first follow-up exam was set 6 weeks after surgery. Additional follow-ups were performed 3, 6 and 12 months postoperatively. The following complications were reported as follows: 2 cases had swelling and redness of the wound. 1 patient had deep vein thrombosis. 1 patient had superficial infection treated by intravenous antibiotics for 1 week without the need of implant removal. 2 patients had deep wound infections with the need of intraoperative debridement and intravenous antibiotics administration for 10 days. 10 patients requested hardware removal. This report is for an unknown synthes one-third semitubular plate. This report is for one (1) unknown construct: plate/ screws. This is report 1 of 1 for (b)(4).

 
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Brand NameUNK - CONSTRUCTS: PLATE/SCREWS
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 Key12053316
MDR Text Key262180013
Report Number8030965-2021-05264
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 05/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2021
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 Received05/28/2021
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: 06/23/2021 Patient Sequence Number: 1
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