Model Number 0131 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2022 |
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.Correction: the correct fda registration number is (b)(4).
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Event Description
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It was reported that there was patient pain that required an additional surgery 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: patient pain.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; re-use of single-use device; use of contrast media; wrong patient or device selection; patient 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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Event Description
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It was reported that there was patient pain that required an additional surgery to remove the device.
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Search Alerts/Recalls
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