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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA SCREW, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA SCREW, FIXATION, BONE Back to Search Results
Device Problem Unintended Movement
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown mid-foot fusion screw / unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review / investigation. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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. (b)(4).

 
Event Description

This report is being filed after the review of the following journal article: n. Hartig , s. Krenn and h. -j. Trnka (2015), surgical treatment of the charcot foot long-term results and systematic review, der orthopade vol. 44(1), pages 14-24 (austria). The aim of this study was to reduce the number of ulcerations and infections, and to minimize the risk of amputation. Between 1999-2011, a total of 43 patients with a mean age of 62. 26 were included in the study. These patients were diagnosed with charcot arthropathy or neuro-osteoarthropathy. The synthes mid-foot fusion bolt was used for the stabilization of the medial column as an alternative to plate osteosynthesis. The mean duration of follow-up was 32. 52 months. The article did not specify which of the devices were being used to capture the following complications: due to infections, a total of 3 amputations had to be performed. 3 patients had reulcerations, 3 patients had pseudarthroses. 6 cases of screw loosenings in progressive talus necrosis. 2 cases of screw fractures. This is report 2 of 3 for (b)(4). This report is for an unknown synthes mid-foot fusion bolt (screw).

 
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Brand NameUNK - SCREWS: TRAUMA
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key9155901
Report Number8030965-2019-69004
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 09/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2019
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 Received09/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/04/2019 Patient Sequence Number: 1
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