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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TI VA-LCP VOLAR DISTAL RADIUS PLATE 4H HEAD/5H SHAFT/RT PLATE, FIXATION, BONE

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SYNTHES GMBH TI VA-LCP VOLAR DISTAL RADIUS PLATE 4H HEAD/5H SHAFT/RT PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.110.206
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
Device report from synthes (b)(4) reports an event as follows: it was reported that on an unknown date, the right-side va distal radius extra articular plate broke due to something falling on the patients hand. Revision surgery was conducted and the broken plate had to be removed; a new construct (plate and screws) was inserted. The procedure was successfully completed. No further information provided. This report is for a plate. This is report 1 of 1 for (b)(4).
 
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Brand NameTI VA-LCP VOLAR DISTAL RADIUS PLATE 4H HEAD/5H SHAFT/RT
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12247088
MDR Text Key264118696
Report Number8030965-2021-06233
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K071184
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.110.206
Device Lot Number6997005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2012
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: 07/29/2021 Patient Sequence Number: 1
Treatment
UNK - SCREWS: DISTAL RADIUS
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