Model Number 179762050 |
Device Problem
Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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Device report from (b)(6) reports an event as follows: it was reported that patient underwent revision surgery on (b)(6) 2022, due to a migrated rod.The surgeon plans to replace screw, rod, and setscrews.The setscrew on the l3 left had thoroughly come off.The setscrew on the l3 right was loose.The rods had come off the lesion.The screws on both sides (had been secured in the lesion.The setscrews, the rods, and the screws were replaced without issue.Patient originally underwent a primary plif procedure (l3/4) on (b)(6) 2022.Postoperative x-rays showed no issue.On (b)(6) 2022, patient was x-rayed again, and images confirmed that a rod had come off the lesion while setscrews had been tightened in place.This report is for a moss miami rod 5.5x50mm ti.This is report 4 of 4 for (b)(4).
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Manufacturer Narrative
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Additional procodes: kwp, kwq, mnh, mni.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Date of concomitant therapy is (b)(6) 2022.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).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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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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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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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.H6: a manufacturing record evaluation was performed for the finished device.Product code: 179762050, lot: bdo1dve.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: december 15, 2020.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the moss miami rod 5.5x50mm ti exhibits markings consistent with the implantation and explantation of the device.No post-operative images to assess the migration condition were provided.A dimensional inspection was unable to be performed due to device design.A functional test was not conducted since the mating device was not returned for examination.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the moss miami rod 5.5x50mm ti was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed, current and manufactured revisions were reviewed.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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