Model Number 186715000 |
Device Problem
Migration (4003)
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Patient Problem
No Code Available (3191)
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Event Date 10/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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Additional product code kwp; kwq; mnh; mni; osh.(b)(4).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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Event Description
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Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for a revision surgery.The patient had posterior lumbar interbody fusion (plif) at l3/iliac treating tumor in the sacrum spine on (b)(6) 2020.It was found that on (b)(6) 2020, the rod had come off and set screws are displaced.It was unknown if the revision surgery successfully completed.The patient outcome was unknown.This complaint involves four (4) devices.This report is for (1) mis single inner set screw.This is report 4 of 4 for (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.H3, h4, h6: since xray/ct scan was not provided, the complaint condition for migration/back out/pull-out cannot be confirmed.There is no indication that a design or manufacturing issue has caused the issue.The root cause could not 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 history lot = the dhr of product code 186715000, lot 279718, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on may 6, 2020.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.H10 additional narrative: h11: corrected data.H4: manufacturing date.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.Manufacturing date.
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Search Alerts/Recalls
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