Model Number 8203126000 |
Device Problem
Material Disintegration (1177)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 4 events were reported for this quarter.Product return status: 4 device investigation types have not yet been determined.Additional information: 4 devices were not labeled for single-use.4 devices were not reprocessed or reused.
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Event Description
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This report summarizes 4 malfunction events in which the device was shedding metal debris.4 events had patient involvement; no patient impact.
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Event Description
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This report summarizes 4 malfunction events in which the device was shedding metal debris.- 4 events had patient involvement; no patient impact.
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10 4 previously reported events are included in this follow-up record.Product return status 1 device was received.3 device investigation types have not yet been determined.
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale 4 previously reported events are included in this follow-up record.Product return status 4 devices were received.
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Event Description
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This report summarizes 4 malfunction events in which the device was shedding metal debris.4 events had patient involvement; no patient impact.
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Search Alerts/Recalls
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