Catalog Number 14-500XXX |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that the tip of a polaris 5.5 dorsal height adjuster stripped intra-operatively when removing a previously implanted iliac screw.The screw was unable to be removed.The reason the screw was being removed is not known.This is report one of two for this event.
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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 report 3012447612-2022-00315.
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Event Description
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It was reported that the tip of a polaris 5.5 dorsal height adjuster stripped intra-operatively when removing a previously implanted iliac screw.The screw was unable to be removed.The reason the screw was being removed is not known.This is report one of two for this event.
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Manufacturer Narrative
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Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the screw was not returned and no photos were provided, so an evaluation was unable to be performed.Root cause: a definitive root cause cannot be determined with the information provided.The positioning of the screw or fusion around the screw may have contributed to the difficulty in removing it.Dhr review: the lot # for the screw was not provided, so the dhr was unable to be reviewed.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
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Search Alerts/Recalls
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