MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Catalog Number 54740004020 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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Pma/510(k) number: this part is not approved for use in the united states; however a like device catalog # 54840004020, 510k # k091974 and udi # (b)(4) was cleared in the united states.X-ray review results: post-op x-ray for thoracolumbar fusion, with growing rod for pediatric scoliosis, was received.No hardware failure was apparent on this x-ray.Product was not 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 fixation at t2-l4 using growing rod due to pediatric scoliosis.On an unknown date, post-op, the screw on the right side of t2 loosened.Fusion of extension also needed to be performed.Hence, the patient underwent a revision surgery, in which screw replacement was performed along with extension of fusion procedure.There was a delay of less than 60 minutes in overall procedure time due to replacement of the loosened screw; however, patient's issue has now been reported as resolved.Reportedly, the patient had undergone multiple surgeries after the initial procedure dated (b)(6) 2018.Extension of fusion was performed on (b)(6) 2018, and (b)(6) 2019.
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