Model Number RA002-5555SL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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The device has not been returned for evaluation and no lab culture results were provided to confirm the reported event.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 a revision procedure was performed due to an infection.No additional information has been provided.
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Manufacturer Narrative
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Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.
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Event Description
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Additional information was received that the revision occurred on (b)(6) 2022.During the revision the surgeon noted that the infection had healed and did not remove the implant.
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Search Alerts/Recalls
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