Model Number 179702000 |
Device Problem
Break (1069)
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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 single-inner setscrew.This is report 3 of 4 for (b)(4).
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Manufacturer Narrative
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Additional procodes: kwp, kwq, mnh, mni, osh.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.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.(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, h4, h6: a manufacturing record evaluation was performed for the finished device, product code: 179702000, lot number: 306735, it was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 26/05/2021.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 single-inner setscrew was nicked.No other product problem was found.A dimensional inspection was unable to be performed due to device design.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the single-inner setscrew would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.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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