MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Catalog Number 54740006545 |
Device Problem
Break (1069)
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Patient Problem
Stenosis (2263)
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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 # 54840006545, 510k #k091974 and udi # (b)(4) was cleared in the united states.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 transforaminal lumbar interbody fusion at l5-s1 and posterior fixation at l4-iliac.On an unknown date, post-op, the screw on the left side of l5 broke and stenosis was observed.Bone-union was achieved.It was planned to replace the broken screw and extend fusion during the revision surgery.On (b)(6) 2019, a revision surgery was performed.The broken part of the screw was very difficult to remove; hence, it was left implanted as it was.Other screws were successfully removed.Fixation was also performed at l4-iliac during this revision surgery.
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Manufacturer Narrative
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Product analysis: visual and microscopic inspection confirmed the mas was returned with the bone screw broken about 10 threads down from the head of the screw.The broken portion of the screw was not returned.The damage would appear to be the result of the removal process.There are beach marks running through the fracture surface indicating cyclic fatigue.When reviewing the saddle of the mas it is noted that the rod does not appear to have been seated evenly in the saddle, which could place extra stress on the screw.The screw will no longer pivot on the crown of the screw.This type of damage is consistent with cyclic fatigue followed by overload.X-ray review results: intra-op imaging from lumbar fusion revision surgery provided.It is unclear which level is shown in images.Description of event says screw broke at l5.There is a screw fragment in the l5 vertebral body.Interbody spacers are present at the levels above and below.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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