Model Number N/A |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation it was implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical product: biomet microfixation screws catalog #: ni lot #: ni.Report source - foreign country: (b)(6).Pma/510(k) number: this product is not cleared or distributed in the u.S.However, this report is being submitted as biomet microfixation manufactures a similar device that is cleared or distributed in the united states under pma number p020016.
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Event Description
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It was reported that the prostheses did not fit as expected.During the implant surgery, the product was implanted as intended, but the occlusion did not fit.The surgeon removed three screws and repositioned the mandibular components.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The complaint cannot be verified, as the product remains implanted and the customer did not provide post-operative ct data.Upon review of the digital design files, the vendor concluded the final splint, mandibular and fossa component samples, and guides were designed according to all applicable procedures per wi 470-500 tmj component design.All of the components of tmjpm-2347 (b)(4)) were inspected for shape and fit as per li0859 & li0860 by trained zb engineering personnel prior to distribution.The dhrs of the components for tmjpm-2347 (b)(4)) were reviewed and there were no anomalies found.The most likely underlying cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Search Alerts/Recalls
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