Model Number TPL0059 |
Device Problem
Malposition of Device (2616)
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Patient Problem
Iatrogenic Source (2498)
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Event Date 04/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a guidance device being used in a spinal procedure.It was reported that the trajectories were low on five of the last 6 cases.The hcp performed an mis tlif.The robot was sent to the l5 and s1 trajectories on the left and right, the skin was marked and then incision was made.The inner and outer drill guide was placed and the pedicle was drilled.The reduction tube was inserted and guidewires placed through the tubes.The c arm was brought in to verify guidewire placement.It was noted that the wires appeared low but should be ok.A tlif was performed and then screws inserted using fluoroscopy.On sunday (b)(6) 2019 the patient had to be brought back to the or to remove the l5 and s1 screws on the patients left side as they were low and the l5 screw appeared to be in the foramen.It was deemed that the screws on the patients right side were low but were still in the pedicle so were left in.There were no additional complications reported or anticipated as a result of the event.
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Manufacturer Narrative
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Evaluation of the returned software export files indicated that a skiving potential was possible at s1 left.The schnaz pin was inserted correctly to the psis and no major issues were detected.The investigation team could not find unambiguous cause for the deviation.The probable causes for these deviations can be related to potential skiving of the tools on the bone, platform shift that caused the screws to deviate in the same manner or surgical technique.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from the manufacturer representative indicated that the system was now working fine.They believed that the arm was replaced.
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Search Alerts/Recalls
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