Catalog Number UNK_SEL |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/07/2022 |
Event Type
malfunction
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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.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 was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.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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As reported: "when the screw was screwed into the distal row, metal came off at the thread".It is unclear as to whether any debris was left in the patient.
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Manufacturer Narrative
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Please note the correction to g1: manufacturing site.
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Event Description
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As reported: "when the screw was screwed into the distal row, metal came off at the thread".It is unclear as to whether any debris was left in the patient.
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Search Alerts/Recalls
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