WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: LCP CLAVICLE PLATE; PLATE, FIXATION, BONE
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Device Problems
Material Deformation (2976); Migration (4003)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Type
Injury
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Manufacturer Narrative
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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.Report is for an unk - plates: lcp clavicle plate unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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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Event Description
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This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) for 234 patients, mean age of 41 ± 18 years (range, 14-77) for synthes clavicle plates.The summary of retrospective data for patients treated with depuy synthes clavicle plates.The following complications were identified: postoperative complications due to, plate fracture due to fall, plate displacement, plate prominence, hardware removal due to patient could fell implant, broken/bent plate due to refracture, pain, impingement.Screw removal, screw back out.This is for the lcp clavicle plate.This is report 1 of 3 for complaint (b)(4).
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Manufacturer Narrative
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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.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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Search Alerts/Recalls
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