Catalog Number 1555200500 |
Device Problem
Migration (4003)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/28/2019 |
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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Patient demographics: gender-male pre-operative diagnosis: procedure: levels implanted:4 it was reported that the patient underwent 3 level oblique lumbar interbody fusion (olif) with 1 level transforaminal lumbar interbody fusion (tlif) due to degenerative scoliosis.Post-op, rod was shifted out from mas screw even through the surgeon did final tightening for the non break off set screw.The patient underwent revision surgery.The surgeon did the revision because the bottom rod shifted out from the last mas screw which is at l5.He changed one new non break off set screw for l5.And from the xray, it showed that the bottom rod was out long enough from last screw.
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Manufacturer Narrative
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Radiographic image results: post-op x rays for multilateral spinal fusion l1-l5.Interbody grafts are present at l1-2, l2-3, l3-4, l4-5.Unable to assess fusion status.The lumbo-sacral transition 3 lordotic.One of the rods is out of the screw head at l5 and appears short for the construct.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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