MEDTRONIC SOFAMOR DANEK USA, INC.; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Device Problem
Break (1069)
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Patient Problem
Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported via a patient call that the patient has underwent a spinal surgery due to infection and scoliosis in her lower back.Post-op, on her 3rd follow up, one of the implanted rod had been broken in half.The patient was given medication as an additional treatment.The patient was in the icu 4 weeks post op and had a picc line through (b)(6) 2018.
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Search Alerts/Recalls
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