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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 Date 03/01/2018
Event Type  Injury  
Manufacturer Narrative

Patient information unknown. This report is for an unknown screw/unknown lot. Part and lot number are unknown; udi number is unknown. Implant date is unknown. Explant date is unknown. Complainant part is not expected to be returned for manufacturer. Without a lot number the device history records review could not be completed. The manufacture date is unknown. 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: agarwal s. , udapudi s. , gupta s. (2018) to assess functional outcome for intra-articular and extra-articular distal femur fracture in patients using retrograde nailing or locked compression plating. Journal of clinical and diagnostic research. Volume 12, number 3, pages 21 - 24 ((b)(6)). The aim of this prospective study was to determine the best functional outcome for distal third femur fracture treated by closed/open reduction using retrograde nailing or locked compression plating in respect to knee-flexion, early mobilization and fracture union and full weight bearing. Between july 2015 to june 2017, 40 patients who were treated for intra-articular and extra-articular distal femur fractures were included in the study. 20 patients with 15 males and 5 females with a mean age of 39. 6 years (group a) were operated with a competitor¿s supracondylar nail system for retrograde nailing, and the other 20 patients with 16 males and 4 females with a mean age of 37. 4 years (group b) were operated with an unknown synthes locking compression plating. All patients were assessed using modified neer¿s criteria which assigns points for pain, function, working ability, joint movements, gross and radiological appearance. All patients were followed up at 6th week, 3 months, 6 months and 1 year postoperatively and thereafter till fracture union was noted. These complications are associated with the patients who were implanted with an unknown synthes lcp: three patients had shortening with an average 1. 5 cm and could be compensated by giving a shoe raise. One case of delayed union in plating group and fracture union occurred after seven months. Two cases of mal-union, which were given physiotherapy. One patient had a fair functional outcome/modified neer¿s score (55 to 69). One patient had a poor functional outcome/modified neer¿s score (less than 55). There were four patients who complained pain at the site of distal screws and two patients who had snapping and which required screw removal after fracture healing. The article does not mention which implant (nail or plate) these complications were associated with. This report is for an unknown synthes locking compression plate. This report is for an unknown screw. This is report 3 of 3 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 Key7677361
Report Number8030965-2018-54929
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 06/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/11/2018
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 Received06/13/2018
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: 07/11/2018 Patient Sequence Number: 1
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