Model Number RA002-4545SL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Metal Related Pathology (4530)
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Event Date 07/11/2023 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
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Event Description
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Information was received that during removal it was noted that metallosis had developed.No additional information has been provided.
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Event Description
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Additional information has been provided.
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Manufacturer Narrative
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Corrected data: d4 (model number and udi number).Additional data: a2, a3, b5, d6a, h10.
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Manufacturer Narrative
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Additional data: b5, h6, h10 a review of the device history record (dhr) confirmed the device met all required quality inspections and specifications prior to release.The rod was not returned for evaluation.This investigation was conducted using the provided photo images.The photos reflected some black debris of an unknown origin on the device.Without the return of the device, no further inspection can be conducted and the root cause cannot be determined.Although a root cause is unable to be determined, objective evidence has determined that there is no direct evidence of any serious or systematic effects due to metallosis and the effects is limited to local tissue discoloration.
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Event Description
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No additional information has been provided.
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Search Alerts/Recalls
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