Model Number 25-660-04-91 |
Device Problems
Migration or Expulsion of Device (1395); Osseointegration Problem (3003)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 04/19/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated report: mdr 9610905-2018-00060 and mdr 9610905-2018-00061.
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Event Description
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It was reported that screws were found no longer fixated in mandibular bone during the consolidation period of a distraction case.The product was removed.Doctor felt adequate consolidation had occurred post-distraction and no additional fixation methods were used.
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Manufacturer Narrative
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The stereo microscope investigation revealed surface damage but no cracks.Further observation determined there were no indications of material or manufacturing defects.The review of the device history records was not possible due to no lot number being identified or provided.The root cause for the failure cannot be determined.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
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Search Alerts/Recalls
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