WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM CORTEX SCREW 3.5MM HEAD/SELF-TAPPING 34MM; SCREW, FIXATION, BONE
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Model Number 201.687 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Foreign Body In Patient (2687); Not Applicable (3189)
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Event Type
Injury
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Manufacturer Narrative
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Date of event is unknown.Part was not explanted, still retained in the patient.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.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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It was reported on (b)(6) 2018, the patient underwent a hardware removal procedure due to wound break down.There are four (4) self tapping metaphyseal screws, four (4) variable angle (va) self tapping locking screws, one (1) va large locking calcaneal plate, and one (1) self tapping cortex screw were removed.One (1) self tapping cortex screw remained implanted due to unknown reason.Originally, the hardware was implanted on (b)(6) 2018.The procedure was completed successfully.Patient status or surgical delay is unknown.This complaint involves eleven (11) device.The other parts associated with this complaint are located in (b)(4).This report is 1 of 1 for (b)(4).
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Search Alerts/Recalls
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