Catalog Number 1910-1271S |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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Sonic anchor (2) failed to fixate.New implants were used with successful fixation.Slight delay in completion of the procedure (5 minutes) and extra holes were drilled to accommodate new implants.
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Manufacturer Narrative
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The reported event could not be confirmed.More detailed information about the complaint event such as the storage conditions (temperature mainly) for instance must be available in order to determine the root cause of the complaint event.The device inspection revealed the following: the device received is completely melted.Therefore, further evaluation of the returned device was not possible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
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Event Description
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Sonic anchor (2) failed to fixate.New implants were used with successful fixation.Slight delay in completion of the procedure (5 minutes) and extra holes were drilled to accommodate new implants.
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Search Alerts/Recalls
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