MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 55711015540 |
Device Problems
Malposition of Device (2616); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2020 |
Event Type
malfunction
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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 # 55811015540, 510k # k122433, 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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Information was received from a health care professional via manufacturer representative regarding screws used in posterior fusion.Levels implanted: t1-11.Pre-operative diagnosis for this procedure ais type2.It was reported that navigation was used from caudal side, the screw was inserted, screws were inserted from the caudal side alternately left and right.It was felt to be deviated a little, so it was checked with ct when coming to th7.It was noted that the screws of the 7th, 8th, and 9th thoracic vertebrae on the left side had deviated.The screw was inserted with navi, but it did not pass through the pedicle and was stuck in the spinal canal.After that, the screw was inserted without using navi with no problem.However, the number of nerve monitoring dropped significantly.After the operation leg moved, but it is unknown at this time whether there were sequelae.The screws were inserted again, and the operation was proceeded and completed.Implant products are being implanted.There was no patient health damage problem.There was a delay of less than 60 min in overall procedure time.
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