MDT SOFAMOR DANEK PUERTO RICO MFG; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Catalog Number 54740006540 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Spinal Column Injury (2081)
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Event Type
Injury
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Manufacturer Narrative
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This part is not approved for use in the united states; however a like device catalog#54840006540, 510k#k091974, udi# (b)(4) was cleared in the united states.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 that the patient underwent posterior lumbar fusion due to lumbar spinal canal stenosis at l3/4/5.Post-op, the implanted screw at l3 loosened.Also, adjacent segment disease (herniation) occurred between l2 and l3 to the patient.The reason for adjacent segment disease is unknown.The patient underwent revision surgery and the screw at l3 was replaced.Pedicle screw was inserted at l2, and fixation was performed at l2/3/4, then the operation was finished.
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