Model Number 93101 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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This report is submitted on 07 april 2021.
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Event Description
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Per the clinic, the patient experienced a loss of ossseointegration resulting in implant loss.There are plans to reimplant the patient with a new device; however, this has not occurred as of the date of this report, (b)(6) 2021.
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Event Description
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Per the clinic, the patient experienced a loss of osseointegration resulting in implant loss.There are plans to reimplant the patient with a new device; however, this has not occurred as of the date of this report, (b)(6) 2021.
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Manufacturer Narrative
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Corrections have been made to b5 (description of event - date of this report), d4 (catalog no and lot no updated), d9 (device available for evaluation), g1 (manufacturing site), h3 (device evaluated by manufacturer), h6 (clinical code & impact code).This report is submitted on (b)(6) 2021.
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Search Alerts/Recalls
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