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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MATRIX LOCK SCREW Ø1.85 SELF-DRILL L6 TA SCREW, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH MATRIX LOCK SCREW Ø1.85 SELF-DRILL L6 TA SCREW, FIXATION, BONE Back to Search Results
Catalog Number 04.511.666.04S
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/03/2018
Event Type  Malfunction  
Manufacturer Narrative

Patient information is unknown. It is unknown if the other screws the package were implanted during the procedure. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Device is not distributed in the united states, but is similar to device marketed in the usa. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been requested. 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2018 during a maxillary osteotomy to fix maxilla plate there were only three (3) screws packed in the brand-new package when opened; there should have been four (4). The surgeon searched for the missing screw, but the surgeon could not find it. The surgery was finished without any other problem. The surgery was completed successfully. There were no surgical delay and adverse consequence to the patient reported. This is report 1 of 1 for (b)(4).

 
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Brand NameMATRIX LOCK SCREW Ø1.85 SELF-DRILL L6 TA
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7906393
MDR Text Key121714281
Report Number8030965-2018-56628
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number04.511.666.04S
Device LOT NumberL942708
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/02/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/21/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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