Product complaint # (b)(4).This report is for an unk - plates: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date the patient underwent for a procedure of fixation the bilateral sacral fracture with previous surgical intervention for total hip prosthesis utilizing a dps sacral bar implant with nuts and washers.Postoperatively, the patient presented hematoma and infection, reoperation was due to hematoma and infection.There was a known healing of fracture reported.Patient outcome is unknown.No further information is available.Concomitant device reported: unk - nuts (part# unknown; lot# unknown; quantity: unknown).Unk - washer (part# unknown; lot# unknown; quantity: unknown).This complaint involves five (5) devices.This report is for (1) unk - plates: trauma.This report is 2 of 2 for (b)(4).
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