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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/3H SHAFT/LT PLATE,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/3H SHAFT/LT PLATE,FIXATION,BONE Back to Search Results
Catalog Number 04.111.531
Device Problem Bent (1059)
Patient Problems Bone Fracture(s) (1870); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Patient information is not available for reporting. Date of event is unknown. Additional device product code: hwc. Device was implanted in (b)(6) 2017; exact date is unknown. 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 initially a patient underwent an open reduction internal fixation (orif) for left extra articular fracture in (b)(6) 2017 and was implanted with variable angle-locking compression (va-lcp) two column distal radius plate. Patient was readmitted post fall. The plate had bent and the wrist had fractured at the same place as original fracture. Patient underwent a revision surgery on (b)(6) 2018. Concomitant devices reported unknown locking screw (part # unknown, lot # unknown, quantity unknown). This is report 1 of 1 for complaint (b)(4).
 
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Brand Name2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/3H SHAFT/LT
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 Key7540889
MDR Text Key109145772
Report Number8030965-2018-53960
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K092556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.111.531
Device Lot Number9695532
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2018
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? No
Date Device Manufactured10/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/24/2018 Patient Sequence Number: 1
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