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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 Date 12/20/2014
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown screw/unknown lot. Part and lot numbers are unknown; udi number is unknown. Without a lot number the device history records review could not be completed. Product was not returned. (b)(4). 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:wurm m. , et al (2014) the midfoot fusion bolt: a new perspective? ,orthopäde, volume 44, pages 65¿70 (austria). This study aims to investigate short-term results in the use of midfoot fusion bolt including complications and review published surveys. Between 2009 and 2014, a total of 16 patients (8 male and 9 female), average age at surgery was 55. 47 (42-70) years, who underwent surgical therapy for midfoot charcot were included in the study. "midfoot fusion bolt" by depuy synthes was used. In all patients, various ao screws and plate sets were also used. Postoperative controls were scheduled after 4 weeks and after 8 and 12 weeks to monitor satisfactory consolidation. An average follow-up interval was 26. 58 (3-55) months. The following complications were reported as follows: two patients died during the aftercare period, but in both cases there was no relation to charcot foot disease. Due to infections, a total of 2 amputations were necessary, with one amputation according to syme being performed. The reasons for the amputations were a chronic osteomyelitis and an infection with ulceration after a minor injury. 3 cases a revision operation had to be performed due to the need to change the osteosynthesis material. Consecutive operations were necessary, 6 of which were screw removal and 2 amputations. Consecutive operations were necessary,4 wound revisions and 3 new arthrodeses. 2 talus necroses. 4 cases where "fusion bolt" were removed postoperatively due to signs of loosening. 2 cases where the "fusion bolt were removed postoperatively were at the request of the patients. This report is for an unknown synthes screws. This is report 4 of 4 for (b)(4).

 
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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 Key9078184
Report Number8030965-2019-68377
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 08/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/17/2019
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 Received08/21/2019
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: 09/17/2019 Patient Sequence Number: 1
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