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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 22MM SCREW, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 22MM SCREW, FIXATION, BONE Back to Search Results
Catalog Number 212.822
Device Problem Unintended Movement
Event Type  Injury  
Manufacturer Narrative

Patient information not available for reporting. Date of device migration is not known. The 510k: this report is for two (2) unknown va locking screws/unknown lot. Part and lot numbers are unknown; udi number is unknown. Date of implant/explant is not known complainant part is not expected to be returned for manufacturer review/investigation. Facility telephone not available for reporting. Initial reporter is synthes sales consultant. 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 the (b)(6) as follows: it was reported patient was implanted with a variable angle (va) distal radius plate and unknown quantity of va locking screws on unknown date. On unknown date it was revealed that two (2) of the va locking screws have backed out. Surgeon states the incorrect drill guide was used and the screws were outside the 15 degree parameter. Patient was returned to surgery on unknown date where the plate and screws were removed. Concomitant device reported: distal radius plate (part number unknown, lot number unknown, quantity 1). This report is for two (2) unknown va locking screws. This is report 1 of 2 for (b)(4).

 
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Brand Name2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 22MM
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ  6805
Manufacturer Contact
michael cote
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key7558627
Report Number8030965-2018-54070
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/31/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number212.822
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/20/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/31/2018 Patient Sequence Number: 1
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