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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VA-LCP OLECR PL 2.7/3.5 R 2HO L90 SST PLATE,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH VA-LCP OLECR PL 2.7/3.5 R 2HO L90 SST PLATE,FIXATION,BONE Back to Search Results
Catalog Number 02.107.202
Device Problems Failure To Adhere Or Bond (1031); Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2017
Event Type  Malfunction  
Manufacturer Narrative

Patient¿s weight is unknown. Additional device product code: hwc. Due to the intra-operative events, the device was not successfully implanted. An alternate device was used to complete procedural step. As such, implant/explant dates are not applicable. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 during a right ulna open reduction and internal fixation (orif) on (b)(6) 2017, surgeon tried to insert the screws but realized that the 2 locking screws are spinning and are not locked. He decided to change to another plate, and mentioned that the plate is faulty. There was an unspecified time delay to procedure. There was no adverse event to patient. Concomitant device reported: locking screws (part # unknown, lo t# unknown, quantity 2). This report is for one (1) 2. 7 mm/3. 5 mm va-lcp olecranon pl 4h/lt/116 mm. This is report 1 of 1 for complaint (b)(4).

 
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Brand NameVA-LCP OLECR PL 2.7/3.5 R 2HO L90 SST
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7163751
MDR Text Key97064399
Report Number8030965-2018-50059
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK120070
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 12/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number02.107.202
Device LOT NumberH288265
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/09/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/07/2017
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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