Catalog Number 07.02010.001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 07/29/2020 |
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 3012447612-2020-00461 to 3012447612-2020-00474, 3012447612-2020-00495 and 3012447612-2020-00496.
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Event Description
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It was reported that a patient underwent a revision surgery to address psuedoarthrosis and back pain.During the procedure it was discovered that the right and left s1 vitality pedicle screws were broken.The screws were removed and replaced with alternate larger screws to complete the case.There were no additional patient impacts reported.This is report twelve of sixteen for this event.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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Information added to d4: unique identifier (udi) number, h6: component codes, health effect-impact code, type of investigation, investigation findings, investigation conclusions.This follow-up report is being submitted to relay additional information and initially corrected information.The complaint is confirmed.Medical records were not provided for review.Device evaluation: the two vitality screw 6.5 x 40 item: 07.02000.074 are fractured as reported the complaint.The remaining returned items were tested but did not show signs of deformation and passed all functional tests.Potential cause: root cause was unable to be determined.This event could possibly be attributed to a traumatic event post-op, failure to follow post-op care instructions, patient factors or other operating conditions that are not known.Dhr review and related actions.Per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use.This device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.Reference reports 3012447612-2020-00461 to 3012447612-2020-00474, 3012447612-2020-00495, and 3012447612-2020-00496.
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Event Description
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It was reported that a patient underwent a revision surgery to address psuedoarthrosis and back pain.During the procedure it was discovered that the right and left s1 vitality pedicle screws were broken.The screws were removed and replaced with alternate larger screws to complete the case.There were no additional patient impacts reported.This is report tweleve of sixteen for this event.
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Search Alerts/Recalls
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