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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/4H SHAFT/RT-STER PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/4H SHAFT/RT-STER PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.111.540S
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2017
Event Type  Malfunction  
Manufacturer Narrative

Patient¿s identifier and weight is unknown. Additional device product code: hwc. The subject device has been received and the product evaluation is in progress. No conclusion can be drawn. A review of the device history records has been requested and is currently pending completion. 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 europe reports an event in (b)(6) as follows: it was reported that osteosynthesis was applied to distal radius fractures on (b)(6) 2017. Hardware removal surgery was performed on (b)(6) 2018 and an incomplete bone-healing area was found where variable angle-locking compression (va-lcp) buttress pin in question was not locked to va-lcp plate during the original surgery. The explant surgery was completed without a delay, and there was no adverse consequence to the patient. Surgeon commented that in the original surgery, the surgeon had difficulty in connecting the buttress pin to the plate. The plate¿s hole concerned was the most distal on the radius side. Although he properly followed the surgical instructions, the buttress pin just span around and could not be tightened to the plate. So, he decided to leave the buttress pin unlocked and completed the original surgery. On the contrary, bone healing was confirmed on the ulnar side where screws had been locked. The surgeon commented that he had completed the original surgery without any technical error. Patient outcome reported as stable. This report addresses the intra-operative issue of buttress pin not connecting to the plate during the original surgery. The postoperative revision due to non-union has been captured under linked complaint (b)(4). This report is for one (1) 2. 4mm ti va-lcp 2-col distal plate. This is report 1 of 2 for complaint (b)(4).

 
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Brand Name2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/4H SHAFT/RT-STER
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7570153
MDR Text Key110174340
Report Number8030965-2018-54129
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK092556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 05/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number04.111.540S
Device LOT Number9658723
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/23/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/30/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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