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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C SCREW, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C SCREW, FIXATION, BONE Back to Search Results
Catalog Number 04.503.104.04S
Device Problem Manufacturing, Packaging or Shipping Problem
Event Date 11/14/2019
Event Type  Malfunction  
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Brand NameMATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ  2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester  
6107195000
MDR Report Key9417406
Report Number8030965-2019-70799
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 11/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/05/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number04.503.104.04S
Device LOT Number3L80064
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 Received11/15/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/19/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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