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 08/17/2023 |
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 two closure tops that migrated out of two reduction screws, allowing the end of two rods 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 rods.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 seven of eighteen for this event.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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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 two closure tops that migrated out of two reduction screws, allowing the end of two rods 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 rods.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 seven of eighteen for this event.
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Manufacturer Narrative
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H6 additional investigation type codes: 4109 and 4110.Device evaluation: product was returned and showed indications of use and removal.X-rays were provided and used to confirm the loosening of all closure tops & migration of two closure tops and the two rods.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: per dhr review, the part was likely conforming when it left zimvie control.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 3012447612-2023-00276 through 3012447612-2023-00293.
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Search Alerts/Recalls
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