MEDTRONIC SOFAMOR DANEK CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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Catalog Number G75446545 |
Device Problem
Malposition of Device (2616)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/04/2017 |
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 # 75446545, 510k #k042025 was approved for sales in the united states.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.
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Event Description
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It was reported that the patient underwent posterior lumbar fusion (plf) at l4-5 due to lumbar canal stenosis.During the surgery, one pedicle screw that was inserted in the patient had deviated.This was found after the surgery was complete.The ct/mri indicated that the pedicle screw (ps) had backed out.The back-out was technical error.Hence, a revision surgery was performed on the same day in which it was explanted completely.The surgeon tried to insert the screw with changing angle of the screw, but the head of mas was completely locked and it could not be engaged with a screw driver.The screw was removed and replaced to the new one with changing the direction.There was a delay of less than 60 minutes in the overall procedure time.No patient complications were reported as a result of this.
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Manufacturer Narrative
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Additional information: product analysis- the screw was returned with the head locked.There are witness marks in the saddle of the screw indicating that the rod and the set screw had been locked into place.The witness marks do not line up with the cut out in the head, indicating the mas was loosened and re-tightened.This does not appear to be a failure of the mas as it appears to have performed to the design intent.If information is provided in the future, a supplemental report will be issued.
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