Model Number L94003 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # = > (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Corail 125 short neck standard neck trial ring is loose.
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Manufacturer Narrative
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Product complaint # (b)(4).All medical device reports associated with the same/similar device(s) and functional : loose were reviewed.It was determined functional : loose has not caused or contributed to any deaths or serious injuries within the time period of jan 1, 2018 ¿ july 12 2022.In total, there have been zero serious injuries and zero deaths reports related to visual : functional : loose in the last 4.5 years.Based on the data, the likelihood of a death or serious injury occurring as a result of the failure is remote; therefore, functional : loose associated with same/similar device(s) of this report will no longer be reported as a medical device report (mdr) unless the event results in a reportable event per 21 cfr 803.50.Correction, this event is considered not reportable after data review.(b)(4).
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Search Alerts/Recalls
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