MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SOLERA VOYAGER SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Catalog Number NAV6640009 |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 01/18/2018 |
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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It was reported that the patient pre-operatively diagnosed with spinal stenosis underwent a surgery at l1-l3.Intra-op, driver's tip sheared off in screw head during final few revolutions of screw placement.Tip of the screw driver is possibly in the head of the screw.However, the x-rays did not show the broken instrument.The broken part might have been removed by suction.No patient complications were reported.
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Manufacturer Narrative
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Visual, microscopic and hardness test was performed.Visually confirmed approximately ~3mm of instrument tip has been broken off, consistent with interface during usage.Inspection of the material hardness confirmed conformance to print specification.Optical examination of the fracture surface identified a fairly flat fracture surface and circular material displacement.The above findings are consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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