Model Number TPL0059 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that after acquiring confirmation images post lumbar procedure with an imaging system, 2 screws that were placed in the right side of the lumbar appeared to be deviated laterally by greater than 3 millimeters (mm).The two screws that were placed on the left side of the lumbar appeared accurate to the initial plan.There was no impact to patient's outcome and there was no surgical delay time.2024-03-22 iud(other): no new information.2024-04-02 iud x2 (other): no new information.
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Manufacturer Narrative
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H3, h6: the exports were returned for clinical analysis.The analysis determined that the probable root cause of the deviations would be inadequate platform fixation, most probably leading to a platform shift.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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