Model Number MSB_UNK_SCREW |
Device Problems
Malposition of Device (2616); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2024 |
Event Type
malfunction
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Event Description
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Information was received from health care provider via manufacturing representative regarding a patient undergone spinal surgery.It was reported that screws malpoistioned and found to be loose during rod seating.Levels implanted l4-5.The right l4 screw was seen to be again lateral (presumably down the original inaccurate trajectory).It was removed and the construct was finalised.There was a delay of more than one hour due to this event.No patient symptoms were reported.No further complications were reported.
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Manufacturer Narrative
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H6: 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.D4: product.G3: pma / 510(k) # unknown.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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Manufacturer Narrative
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B5 updated with additional information.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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Additional information was received from rep that this was a clinical issue and not related to the implant malfunctioning.
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Search Alerts/Recalls
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