Model Number PS11.5-50SJ235 |
Device Problem
Corroded (1131)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
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Event Description
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Information was received that a nail was found to have corrosion at the distraction rod junction and locking screw holes.The nail was said to be otherwise fully functional.There was no report of patient impact in association with the rod.
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Event Description
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No additional information was provided.
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Manufacturer Narrative
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Device evaluation: visual inspection of the returned nail revealed that the distraction rod of the nail had discoloration which confirmed the reported failure mode.Per reported failure functional testing was not applicable.The discoloration failure is a previously known issue.A capa has been initiated to address the reported failure.Device records review: a review of device history records for the returned unit confirmed that it met all the required quality inspections prior to release.
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Search Alerts/Recalls
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