OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: 3.5 MM CANNULATED; SCREW, FIXATION, BONE
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Synovitis (2094); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown a cannulated ao/asif small cancellous screw (3.5 mm)/ unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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).
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Event Description
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This report is being filed after the review of the following journal article: senekovic, v.And veselko, m.(2003), anterograde arthroscopic fixation of avulsion fractures of the tibial eminence with a cannulated screw: five-year results, the journal of arthroscopic and related surgery, vol 19, no 1, pages 54-61, (slovenia).The goal of this study was to evaluate the 5-year results of arthroscopic reductions and anterograde fixations of the tibial eminence fracture with cannulated screws.Between 1995 and 1999, 32 patients (15 females and 17 males) with an average age of 22 years (range, 8 to 53 years) were treated with cannulated ao/asif small cancellous screw (3.5 mm) with washers.Fractures were fixed with a screw and washer in 26 patients, 2 screws and washers in 5 patients, and 2 screws in 1 patient.Average time from implantation to removal was 11.7 weeks (range, 5 to 53).Average follow-up for the 32 patients was 37.5 months (range, 16 to 69).The article did not specify which of the devices were being used to capture the following complications: 1 patient had aseptic synovitis.This report is for a cannulated ao/asif small cancellous screw (3.5 mm).This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: a1: multiple patient involved.D3: event date is unknown.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.
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