OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 70MM; APPLIANCE, FIXATION, NAIL
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Catalog Number 413.370 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Skin Erosion (2075)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Exact date of event is unknown; event reportedly occurred in 2018.It is unknown if the complainant part is available to be returned for manufacturer review/investigation, but it has yet to be received.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.
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Event Description
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Device report from synthes (b)(4) reports an event as follows: it was reported that on (b)(6) 2018, the patient underwent an orthopedic procedure for hardware removal of one (1) locking compression plate (lcp) proximal tibial plate, five (5) locking screws and two (2) cancellous bone screw, due to serious generalized skin fragility and dehiscence of the wound.Originally, the patient underwent an osteosynthesis of the left external tibial plate, on (b)(6) 2018.There was a fifty-five (55) minute surgical delay reported.Patient outcome was unknown.This report is for a locking screw.This is report 7 of 8 for (b)(4).
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Search Alerts/Recalls
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