Model Number PS10.0-50D235 |
Device Problem
Failure to Advance (2524)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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No product was returned for evaluation nor were radiographs or images provided to confirm the alleged event.Even though root cause cannot be confirmed based on reported information premature consolidation of patient's bone may have contributed to the alleged event.
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Event Description
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Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter the nail failed to lengthen.
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Manufacturer Narrative
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The customer¿s report that the nail failed to lengthen was not confirmed; the returned precice stryde was observed and no damage was found.X-ray images of the internal components showed no damage and revealed the nail to be partially distracted.The nail was functionally tested and was able to distract and retract with the erc and high speed magnet.The root cause for the customer¿s report was not determined.Review of the device history record for the nail confirmed that it met all the required quality inspections.Complaint records show similar failures reported in the past.
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Event Description
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Correction: d.4 (lot number).
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Search Alerts/Recalls
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