Catalog Number IMPDTL |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2021 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint number (b)(4).
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Event Description
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It was reported that implant driver was used to finalize placement and internal threads of the implant stripped at tooth location # 14 and had to be removed with trephine.New implant was place at this visit.No injury to patient other than implant being removed.No permanent impairment.Impdtl was reported as the driver tip used when the damage to the implant happened.
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Manufacturer Narrative
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The following sections have been updated: a3: gender.B4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H10: added manufacturer narrative.
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Event Description
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No further event information available at the time of this report.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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One 3i t3® tapered implant 6/5 x 11.5mm (bopt6511) was returned for investigation.The reported impdtl driver tip was not returned for inspection.Visual inspection of the as returned product identified signs of damage at the implant internal threads.No pre-existing conditions were noted on the per.The reported product was located on tooth # 14 (universal) and removed the same day as placement.The reported event could not be recreated due to the nature of the dental device and event (damage).The customer has not provided additional pictures or x-ray images of the product.Appropriate documentation was reviewed.Dhr review: (bopt6511).Dhr review was completed for the subject lot number 2020021279.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.(impdtl) - dhr review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Complaint history review: (bopt6511) - complaint history review was performed for the reported lot number (2020021279) for similar event and 1 other complaint was identified utilizing keyword(s) -damage- under (b)(4).(impdtl) - a complaint history review by item number was conducted for the impdtl dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product utilizing keyword(s) -damage-.Based on the available information, device malfunction has occurred and the reported event, as it relates to the returned implant, was confirmed.Functionality of the reported driver could not be verified without device return.
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Search Alerts/Recalls
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