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Catalog Number T43110INT |
Device Problem
Device Appears to Trigger Rejection (1524)
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Patient Problem
Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Hcps review based on donor records: after reviewing the donor records, and the complaint of the surgeon, the hcps see no objective evidence that the graft was the cause of the patient¿s ¿relapse¿.The fact that there was ¿no post-op infection, or immunological or inflammatory response¿ reinforces their conclusion.Manufacturing assessment: no deviations from established procedures were noted that may have increased the risk of contamination/cross contamination.All supplies and reagents utilized were inspected upon receipt and prior to recovery.The supplies and reagents were stored as per packaging or manufacturer recommendation in a temperature controlled environment.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient underwent laminectomy and posterior arthrodesis at l4-l5.During the surgery, the surgeon placed 10 cc putty into the patient.No cage was used; the surgeon only put screws and rod manufactured by medi implants.No intra-operative complications were reported.Approximately a week after the surgery, reportedly, the patient had a relapse and had low levels of saturation among other symptoms.The patient reported experiencing a rare feeling.The surgeon planned a revision surgery due to this event.On (b)(6) 2019, the revision surgery was performed.When the wound was opened, it was observed that the graft had a black-gray color and had an abnormal appearance.The surgeon then commented that the graft was bad and that the patient's body could have rejected the graft.Hence, everything implanted during the initial surgery was completely explanted.The items that were explanted included the reported graft, the screws and the rod.The patient had to be hospitalized due to this event.There was no post-op infection, or immunological or inflammatory response reported.Patient issue has been reported to be resolved.
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Search Alerts/Recalls
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