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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Not Applicable (3189)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown lcp plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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It was reported patient was implanted with a locking compression plate (lcp) plate and an unknown quantity of screws on (b)(6) 2017.On unknown date patient developed symptomatic hardware pain.Patient was returned to surgery on unknown date where all hardware was removed.This report is for one (1) unknown lcp plate.This is report 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The initial complaint was reviewed and found not reportable.Follow up information was received from the reporter stating that the plate functioned as intended and the screw broke post-op instead.Therefore, the plate will be non-reportable.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.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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A hardware removal of the locking compression plate and an unknown number of screws had been scheduled for (b)(6) 2018.However, the procedure was cancelled and has not been rescheduled.Patient outcome is not specified.
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Search Alerts/Recalls
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