Catalog Number PDL-L-PT14S |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Event Description
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It was reported that there was a revision procedure done on (b)(6), 2014.The pro disc l (pdl) implant was removed because the surgeon stated the height of the pdl was too big, limiting the device's ability to move.The device was removed easily and there were no reported device issues.This report is for an unknown pro disc l poly inlay.This is report 2 of 3 for (b)(4).
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Manufacturer Narrative
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Patient id reported as (b)(6).This report is for an unknown pro disc l poly inlay/unknown lot.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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Manufacturer Narrative
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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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