Catalog Number 07.02010.001 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/14/2023 |
Event Type
malfunction
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Event Description
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It was reported that a revision surgery was performed on a vital construct to address a closure top that migrated out of a reduction screw, allowing the end of the rod to also migrate post-operatively.During the revision, six additional closure tops were found to be loose (but did not migrate) in their reduction screws.The closure tops were removed and replaced; the surgeon elected to use the existing reduction screws and rod.It was also reported that the surgeon did not use the reduction screw tab sleeve during the initial procedure; the use of the reduction screw tab sleeve is required during closure top insertion and provisional tightening when using reduction screws per the device labeling.This is report fourteen of fifteen 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.
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Event Description
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It was reported that a revision surgery was performed on a vital construct to address a closure top that migrated out of a reduction screw, allowing the end of the rod to also migrate post-operatively.During the revision, six additional closure tops were found to be loose (but did not migrate) in their reduction screws.The closure tops were removed and replaced; the surgeon elected to use the existing reduction screws and rod.It was also reported that the surgeon did not use the reduction screw tab sleeve during the initial procedure; the use of the reduction screw tab sleeve is required during closure top insertion and provisional tightening when using reduction screws per the device labeling.This is report fourteen of fifteen for this event.
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Manufacturer Narrative
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H6 additional code: 4109.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned and no photos were provided.X-rays were provided and used to confirm the loosening of all closure tops & migration of one closure top and the rod.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown surgical, patient or traumatic factors.It is possible that the reduction tab sleeves were not used as stated in the event description.Without operational notes, however, that cannot be determined for certain.Dhr review: dhr review unable to be performed as lot information is not known.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.Reference reports 3012447612-2023-00261 through 3012447612-2023-00275.
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Search Alerts/Recalls
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