Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.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 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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It was reported that on an unknown date, the patient underwent for a fracture removal surgery for a shaft fracture utilizing an lcp superior-anterior clavicle plate.There was a union of fracture after 12 weeks duration.1 year postoperatively, hardware removal was reported due to patient could feel the implant.Patient outcome is unknown.No further information is available.Concomitant device reported: unknown screws: cortex (part# unknown; lot# unknown; quantity: 6).This complaint involves seven(7) devices.This report is for (1)3.5mm lcp sup ant clavicle pl w/lat extn 3h/lt/69mm.This report is 1 of 7 for (b)(4).
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