SYNTHES USA 5.0MM CANNULATED VA LOCKING SCREW/90MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
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Catalog Number 02.231.690 |
Device Problems
Loose or Intermittent Connection (1371); Unintended Movement (3026)
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Patient Problems
Wound Dehiscence (1154); Failure of Implant (1924)
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Event Type
Injury
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Event Description
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It was reported that a left femoral variable angle condylar plate and screws were implanted approximately three (3) weeks ago during an open reduction internal fixation (orif) procedure of a left, periprosthetic distal femur fracture.On an unknown date thereafter, the patient experienced left lateral hip wound dehiscence.The patient required a second surgery as a result of the wound dehiscence and the discovery of two (2) screws backing out of the plate.During the revision, it was determined that all the distal locking screws were loose.The plate remained implanted, but five (5) new screws were utilized.The procedure was successfully completed with no surgical delay reported.This report is 1 of 6 for (b)(4).
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Manufacturer Narrative
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Additional patient information: patient height is reported as (b)(6).Patient identifier is not available for reporting.Patient weight is reported as being between (b)(6).Date of postoperative event is unknown.Additional product codes for this report include: hrs and hwc.Exact date of original procedure is unknown, but occurred approximately three (3) weeks ago.Per facility, the complainant parts are not available for return.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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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Search Alerts/Recalls
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