Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1, d2, d3, d4, g4 ¿ 510k: this report is for an unknown plates: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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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Device report from synthes reports an event in united kingdom as follows: it was reported that on an unknown date, the case was stuck in surgeon approval and therefore never shipped to the hospital.It was not entirely clear yet how it happened.Surgeon asked to position the orbital implant close to the previous screw holes of the existing metal plate.This should help with positioning of the orbital implant.The previous plate needs to be removed before the orbital implant fits, as there was a small intersection.There is a very small gap between the peek implant and the orbital implant.Procedure and patient outcome were unknown.This report is for one (1) unk - plates: trauma this is report 1 of 1 for complaint (b)(4).
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