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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SCREW, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH SCREW, FIXATION, BONE Back to Search Results
Device Problem Unintended Movement (3026)
Patient Problem Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative

510k: this report is for an unknown screw/unknown lot. Part and lot numbers are unknown; udi number is unknown. Date of explant reported as (b)(6) 2018, exact date is not known. Complainant part is not expected to be returned for manufacturer review/investigation. 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 (b)(4) reports an event in (b)(6) as follows: it was reported patient underwent an opening wedge high tibial osteotomy for gonarthrosis on (b)(6) 2017. One (1) tomofix medial high tibial plate-right and artificial bone materials were implanted at that time. Post-operatively, patient underwent the partial-weight-bearing rehabilitation. During an unknown rehabilitation period, it was noted the anterior area of the implanted artificial bones showed bone healing, but bone healing was not noticed in the posterior area. Artificial bones in the posterior area were backed out and the bumped bones could be recognizable from the skin. Because further bone healing could not be expected, the artificial bones were explanted in (b)(6) 2018. This report is for one (1) unknown screw this is report 2 of 2 for (b)(4).

 
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Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7343106
MDR Text Key102576473
Report Number8030965-2018-52120
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 HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 02/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2018
Is This An Adverse Event Report? Yes
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 Received04/13/2018
Was Device Evaluated By Manufacturer? No Answer Provided
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: 03/15/2018 Patient Sequence Number: 1
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