Model Number 01-335-06-09 |
Device Problem
Failure to Osseointegrate (1863)
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Patient Problems
Erosion (1750); Impaired Healing (2378); Patient Problem/Medical Problem (2688)
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Event Date 02/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event and patient, please see associated report: mdr 9610905-2018-00024; mdr 9610905-2018-00032; and mdr 9610905-2018-00033.
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Event Description
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It was reported that plates and screws were removed due to patient condition, osteonecrosis of the bone.Ifu (b)(4) contraindications include "patient conditions including: blood supply limitations, insufficient quantity or quality of bone or latent infections.".
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Manufacturer Narrative
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An investigation was performed using visual and stereo microscopic inspection on the product returned.There were no indications of material or manufacturing defects.The results of the investigation have concluded that no failure was found.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.Product for this patient is captured on mdr 9610905-2018-00024; mdr 9610905-2018-00025; mdr 9610905-2018-00032; and mdr 9610905-2018-00033 and follow ups.
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Search Alerts/Recalls
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