Model Number RA002-4545SL |
Device Problem
Break (1069)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been returned for evaluation.Root cause is unable to be determined at this time.The reported event has been addressed in the device labeling.
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Event Description
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Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter, x-ray images revealed that the magec rod was broken.The patient is healthy and doing well.
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Manufacturer Narrative
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Device records review: review of the device history record for the rod confirmed that it met all of the required quality inspections and release criteria.Device evaluation: visual inspection of the returned product identified a fractured rod.As part of this investigation, functional testing and x-ray did not apply due to the condition of the rod.The rod's work order and inspection data was reviewed and confirmed the rod passed all inspections and met all design specifications and there is no indication a manufacturing issue contributed to the fracture.The type of breakage observed indicates the fracture is a result from patient¿s daily activities.
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Event Description
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No additional information was provided.
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Search Alerts/Recalls
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