Catalog Number 2000-1005 |
Device Problem
Migration (4003)
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Patient Problems
Death (1802); Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)
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Event Date 07/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2020-00376 to 3012447612-2020-00391.
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Event Description
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It was reported that a patient underwent a revision surgery after experiencing postoperative pain and discomfort.Sixteen plugs were found to have migrated, they were removed and replaced with alternates to complete the case.There were no additional patient impacts reported.This is report nine of sixteen.
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Event Description
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It was reported that a patient underwent a revision surgery after experiencing postoperative pain and discomfort.Sixteen plugs were found to have migrated, they were removed and replaced with alternates to complete the case.There were no additional patient impacts reported.Additional information was provided which stated the patient has passed away due to covid-19 and it is not believed that the polaris construct contributed to the patient¿s passing.This is report nine of sixteen.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow-up report will be sent upon completion of the device evaluation.
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Event Description
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A subsequent additional update was reported stating that the patient has not passed away but was admitted to the er for a l5 pedicle fracture and vertebral body fracture and was reported to be bedridden.No procedures have been scheduled, and the most recently received update was that the patient was discharged from the hospital.
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Event Description
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It was reported that a patient underwent a revision surgery after experiencing postoperative pain and discomfort.Sixteen plugs were found to have migrated, they were removed and replaced with alternates to complete the case.There were no additional patient impacts reported associated with this event.This is report nine of sixteen.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The complaint is confirmed for sixteen returned polaris closure tops for the failure of loosening due to screw fracture/ disassembly from improper use.Medical records were not provided for review.Device evaluation: visual inspection: the 15 of the 16 closure tops were returned to westminster for evaluation.The identities of the device were confirmed for those originally reported with 11 unknown lot numbers and 4 known lot numbers.All closures tops had the underside ring deformed and discolored and the pointed center dot featured flattened, indicating proper tightening to the rod.There are slight cosmetic wear marks on the sides, but otherwise no visible damage on the threads or elsewhere on the closure tops aside from slide wear from implantation and explantation.Functional test: all 15 returned closure tops were successfully tightened down to a test in a sawbone apparatus with a test bent using a polaris plug starter.Potential cause: root cause was unable to be determined.This event could possibly be attributed to screw damage due to use with an spf device.Dhr review and related actions: the lot number was not discernible on this device, so the dhr was unable to be reviewed.Device use: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Search Alerts/Recalls
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