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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
Event Type  Injury  
Manufacturer Narrative

510k: this report is for an unknown locking 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. 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. (b)(4).

 
Event Description

This report is being filed after the review of the following journal article: sharma, g. M. Et al (2017), treatment of three-and four-part proximal humerus fractures by multiloc nailing technique- a prospective study. Journal of clinical and diagnostic research, volume 11, no. 11, pages 9-11 (india) the aim of the prospective study was to study the functional and radiological outcome of patients with three-and four-part proximal humerus fractures treated with multiloc nailing system between december 2013 and february 2015. There were 21 patients (7 males and 14 females), who were above 60 years old, with three- and four-part proximal humerus fracture treated with synthes multiloc® proximal humerus nail. The proximal multiple locking was done using the 3. 5mm and 4. 5mm screw in screw. Ascending screws were then inserted followed by distal locking. Regular follow-up was done for all the patients at one, three, six, 12 and 24 months respectively. Complications were reported as follows: there was one case of varus collapse which showed malunion. There were no clinical symptoms and thus, no active intervention was done for the same. There were two cases of shoulder impingement in the present study. Constant score showed one case having fair functional outcome, and one case having poor functional outcome. There was one case in which there was articular surface intrusion of the screw, which was removed at a later date after six months. This report is for an unknown locking screw this is report 5 of 5 for (b)(4). A copy of the literature article is being submitted with this medwatch.

 
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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 Key7409630
Report Number8030965-2018-52917
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type LITERATURE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2018
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 Received03/14/2018
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: 04/09/2018 Patient Sequence Number: 1
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