ZIMMER BIOMET SPINE INC. OPEN IMPLANT CLOSURE TOP, 5.5MM, TI; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
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Catalog Number 3301-1 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that during surgery, three closure tops stripped on three different screws.Three new closure tops were used to complete the case.There was no impact to the patient.This is report one of three 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.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 3012447612-2022-00129 through 3012447612-2022-00130.
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Manufacturer Narrative
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Corrections in d4: udi number, d9, and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed no damage to either the screw drives or threads.Potential cause: root cause was unable to be determined as no product issue was identified.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device use: 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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Event Description
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It was reported that during surgery, three closure tops stripped on three different screws.Three new closure tops were used to complete the case.There was no impact to the patient.This is report one of three for this event.
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Search Alerts/Recalls
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