Catalog Number 254401014 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 09/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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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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It was reported that the sterilization reported a missing ballspring on the spacer block.
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Manufacturer Narrative
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It was reported that the sterilization reported a missing ball spring on the spacer block.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Search Alerts/Recalls
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