Model Number 1320-3642S |
Device Problems
Break (1069); Fracture (1260)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
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Event Description
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It was reported that the device broke.
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Manufacturer Narrative
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The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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It was reported that the device broke.
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Search Alerts/Recalls
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