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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VA LOCKSCR Ø2.4 SELF-TAP L20 TAN SCREW,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH VA LOCKSCR Ø2.4 SELF-TAP L20 TAN SCREW,FIXATION,BONE Back to Search Results
Catalog Number 04.210.120
Device Problem Manufacturing, Packaging or Shipping Problem
Event Type  Malfunction  
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Brand NameVA LOCKSCR Ø2.4 SELF-TAP L20 TAN
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
eimattstrasse 3
oberdorf  4436
  4436
6103142063
MDR Report Key9181640
Report Number8030965-2019-69279
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 09/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number04.210.120
Device LOT Number14L9107
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 Received11/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/16/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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