Model Number ILPC442U |
Device Problem
Fracture (1260)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of the event unknown / not provided.Email address was not provided.
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Event Description
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Doctor reported the screw fractured of the low profile abutment in tooth location 19.Doctor was able to remove the fracture portion and replaced the abutment.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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Zimmer biomet complaint number (b)(4).Two certain® low profile one-piece abutments (ilpc443u & ilpc442u) and one unknown legacy biomet abutment were returned for investigation.Visual evaluation of the as returned products identified that the abutments were fracture across the threads.Device history record (dhr) review for the lots (2018112357 & 2019080123) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the lot (2018112357 & 2019080123) for similar events and no other complaint was identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.
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Search Alerts/Recalls
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