Model Number 24-009-11-71 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Non-union Bone Fracture (2369); Impaired Healing (2378)
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Event Date 04/23/2019 |
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: mdr 9610905-2019-00125, mdr 9610905-2019-00126, mdr 9610905-2019-00127, mdr 9610905-2019-00128.
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Event Description
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It was reported device was removed due to patient condition.
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Manufacturer Narrative
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An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The failure root cause cannot be determined due to the device not being returned.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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