Device product code: ni.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 3012447612-2019-00499 to 3012447612-2019-00511.[mw5090393.Pdf].
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It was reported that a patient underwent a revision surgery where eight plugs, two rods, two screws, and one cross connector were removed.It was reported that two screws were fractured.No further surgical information or additional patient impacts were reported.This is report thirteen of thirteen.
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(pce80791: pn2000-24xx).The complaint is confirmed for 2 (two) of 2 (two) unreturned polaris 5.5 titanium screw (pn 2000-24xx) for the reported failure of fracture.The severity of this event is 3 (rmr-00090).Without further information, the cause of this failure cannot be determined.It is possible that the patient underwent a traumatic incident (such as a fall) which led to this event.However, no information was provided to indicate this.No other defects could be determined for the remaining item numbers 2000-1005, 2000-51xx, 9467x.The lot numbers were not provided, so the dhr's are unable to be reviewed.Review of complaint history for pn 2000-24xx identified 1 additional complaint for the same part number for the same or similar issue.No complaint search was performed for pn 2000-1005, 2000-51xx, and 9467x as no defects were noted and the complaint was initiated for the issue of two fractured screws with pn 2000-24xx.The devices are used for treatment.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.No medical records were provided for review.A definitive root cause cannot be determined.No action is recommended at this time.
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