Model Number 1910-1272S |
Device Problem
Activation Failure (3270)
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Patient Problem
Failure of Implant (1924)
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Event Date 11/05/2021 |
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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The customer reported the following: "on (b)(6) 2021, the sonic anchor implant was not 'melting' correctly and was pulled out of the patient's foot.Through trial and error, several more implants also failed to 'melt' correctly.Drilled and then try to implant bioabsorbable piece.Sonic anchor is only melting top portion of implant.Troubleshooted the machine today and it did not work.Surgery was completed with a sonic anchor from another company.Reporter will provide the product catalog information for the machine later.".
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Manufacturer Narrative
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Please note correction to section d9/h3, the device was not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.H3 other text : device disposition is unknown.
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Event Description
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The customer reported the following: "on (b)(6), 2021, the sonic anchor implant was not 'melting' correctly and was pulled out of the patient's foot.Through trial and error, several more implants also failed to 'melt' correctly.Drilled and then try to implant bioabsorbable piece.Sonic anchor is only melting top portion of implant.Troubleshooted the machine today and it did not work.Surgery was completed with a sonic anchor from another company.Reporter will provide the product catalog information for the machine later.".
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Search Alerts/Recalls
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