Model Number 0279401200 |
Device Problems
Loss of or Failure to Bond (1068); Material Erosion (1214)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the glue adhesive was flaking during the procedure.
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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: adhesive peels off probable root cause: non-conforming component.Poor assembly process.Misuse.Use error.The reported failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that the glue adhesive was flaking during the procedure.
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Search Alerts/Recalls
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