MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Catalog Number 7578301 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis: it is possible that with excessive force the extender could be popped off the head.During normal use, the extenders would appear to function properly.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 patient underwent transforaminal lumbar interbody fusion (tlif) with posterior fixation.During surgery, there was an audible pop sound and the tower came off.The screw and the tower at l5 were then replaced with new ones.Then both the persuaders were reduced down to 4mm.The s1 set screws were engaged but the l5 set screw would not engage so persuader was reduced to just a 1 mm more and this is when the tower popped off of the screw again, but just on one side.At this point, the l5 screw was switched, tlif was completed and screws and a rod were put on the patients left side with no further issues.The product came in contact with the patient.No patient complications were reported as the result of the event.
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