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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: LOCKING SCREW, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: LOCKING SCREW, FIXATION, BONE Back to Search Results
Device Problems Break; Unintended Movement
Event Type  Malfunction  
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Brand NameUNK - SCREWS: LOCKING
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key9162248
Report Number8030965-2019-69102
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/20/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/07/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received10/10/2019
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

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