Catalog Number 1556300500 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Code Available (3191)
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Event Date 11/17/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) (revision surgery).Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Date of initial surgery: "(b)(6)" initial surgery levels implanted: l5(r)-il(lr): posterior fusion pre-operative diagnosis: sacrum fracture (vertical crack at right side) procedure: posterior spinal fusion levels implanted: right iliac it was reported that post-op, rod at right side of iliac was migrated.Patient underwent revision surgery for fixation of rod.No patient complications were reported as a result of this event.
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Manufacturer Narrative
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Image review: post-op x-ray are provided from l5 to iliac stabilization from sacral fracture.A unilateral fixation point is present at l5, and the construct eventually failed at the iliac sacral connector.I am unfamiliar with this stabilization technique but suspect the construct strength is not sufficient to immobilize the lumbo-sacral junction.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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This device is not approved for sale in usa but a similar device with catalogue#1553201035, upn# (b)(4) and 510k# k113174 is approved for sale in usa.Product analysis: visual and optical examination of the rod identified asymmetrical set screw witness marks near the ends of the rod.Mid-section of the rod displays multiple surface marks consistent with rod bending for anatomical contouring.No additional wear, deformation, crack, or fracture is noted.The asymmetrical witness marks suggest possible final tightening of one side of the rod prior to fully seating the other.This could create a pre-load on the opposite side, resulting in premature break-off of the associated set screw.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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