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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Osteolysis (2377); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
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: kahle, m. , david, e. ,filler, r. D. , gressner, v. (1992), the dynamic condylar screw (dcs) in proximal femoral fractures. Initial experiences, unfallchirurgie, vol. 18, pages 44-47 (germany) doi: 10. 1007/bf02588239. The aim of our study was to examine the suitability of the dcs for the treatment of proximal femur fractures. Since january 1, 1987, a total of 19 patients (13 females and 6 males, aged 37 to 97 years, mean age 70 years) who had proximal femoral fractures were stabilized utilizing the "'dynamic condylar screw" (dcs). In the cases we applied the dcs hitherto employment of a bone distractor of complementary cancellous bone graft has been mandatory. An average of eight weeks after the procedure the patients were fully loaded. The following complications were reported as follows: a (b)(6) year-old male patient who had already had a lower-leg amputation as a result of arterial occlusive disease on the operated side presented himself with primarily good results and full load with prosthesis six months after the intervention with almost eliminated mobility in the left front joint. X-ray showed massive periarticular calcification with proper implant seat and bone consolidation of the fracture. Functionally, not least also as a result of a lack of cooperation on the part of the patient, this status could not be improved. 2 patients complained of weather-dependent thigh pain. 1 patient, 13 weeks after the first operation x-rays showed osteolysis in the area of the distal plate screw. We operated again, removed the 8-hole plate, and pushed a longer plate onto the screw that remained in the femoral collar. Subsequently, the tumor masses were cleared out, bone cement was inserted and the composite osteosynthesis ended after screwing this report is for an unknown synthes plate. It captures the reported osteolysis in the area of the distal plate screw, removed the 8-hole plate and pushed a longer plate onto the screw. This is report 2 of 4 for (b)(4).
 
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Brand NameUNK - PLATES
Type of DevicePLATE, 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 Key10351028
MDR Text Key201237073
Report Number8030965-2020-05540
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received07/10/2020
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: 07/31/2020 Patient Sequence Number: 1
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