Catalog Number IIPDTUS |
Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2022 |
Event Type
Injury
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Event Description
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It was reported that tool cannot be disengaged from the implant at tooth site 27.
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Manufacturer Narrative
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Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Lot/serial # unknown / not provided.Device expiration date unknown / not provided.Device udi number unknown / not provided.Device manufacturer date unknown / not provided.
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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).One (1) internal connection universal placement driver tip - short (iipdtus) and one (1) 3i t3 with dcd non-platform switched parallel walled implant 4 x 10mm (bnss410) were returned for investigation.Visual inspection of the as returned products identified bone debris on external threads.Functional testing was performed for the returned products.It was confirmed that the implant and placement driver would not disengage from each other.Malfunction.Pre-existing conditions were not noted on the per form.Bone density was unknown.The reported device had been placed on tooth #43 (fdi).Dhr review and complaint history review by lot number could not be performed, as the lot numbers associated with the reported product are not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review by item number was conducted for the (iipdtus) dating back to 12 months prior to the notification date.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported device related to the reported event.Review completed utilizing keywords: functional : does not disengage/release.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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