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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 28MM SCREW, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 28MM SCREW, FIXATION, BONE Back to Search Results
Catalog Number 212.208
Device Problem Unintended Movement
Event Type  Injury  
Manufacturer Narrative

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 reports an event in (b)(6) as follows: it was reported that a patient underwent a surgical procedure on an unknown date, more than a year ago. The patient experienced persistent pain, and x-ray images taken showed screw failure. Concomitant device reported: unknown plate, (part # unknown, lot # unknown, quantity unknown). This is report 7 of 10 for (b)(4). This complaint has been updated with the 10 of 13 devices. Please see the linked complaint (b)(4) for the additional two devices.

 
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Brand Name5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 28MM
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key9396195
Report Number8030965-2019-70639
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number212.208
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 Received12/05/2019
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: 12/02/2019 Patient Sequence Number: 1
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