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

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).

• Brand Name: UNK - PLATES
• Type of Device: PLATE, 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 Key: 10351028
• MDR Text Key: 201237073
• Report Number: 8030965-2020-05540
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention