Model Number 0131 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient developed an infection and required a wash out.
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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 the patient developed an infection and required a wash out.
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Manufacturer Narrative
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Correction: the incorrect fda registration number was used during the initial report.The correct fda registration number is 3016573902.The manufacture date is not known.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 factors chills and fever probable root cause: design: - wrong raw material or manufacturing agent selected.- in-process cleaning not effective at removing manufacturing residuals.- not enough strict controls placed on raw material source and purity.Process: - sterilization fault - including eto residuals.- contamination during manufacturing process; including endotoxins.- in-process cleaning not performed to spec.Application: - contamination of instruments.- patient reaction/allergy sensitivity or with active/latent infection.- use of contrast media.- use of more than one implant within the shoulder.- wrong patient selection.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
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Search Alerts/Recalls
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