Catalog Number 0129 |
Device Problem
Device Appears to Trigger Rejection (1524)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that a revision surgery will be needed to remove the device.
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Event Description
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It was reported that a revision surgery will be needed to remove the device.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: pain post operation probable root cause: design - inadequate raw material specification process - spacer not manufactured to specification - incorrect material used during manufacture - incorrect packaging or error in packaging process causes exposure to humidity or high temperatures application - use of expired product - wrong storage conditions (high temperatures or exposure to humidity <40%) - re-use of single-use device - use of contrast media - wrong patient or device selection - patieint not following rehab procedure the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
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Search Alerts/Recalls
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