Catalog Number 482617050 |
Device Problems
Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191); Migration (4003)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 03/04/2019 |
Event Type
Injury
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Event Description
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It was reported that the screw was found to be loose.The patient was in pain and revision surgery was performed for replacement of hardware, upsize screws and fuse posterior lateral.
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Event Description
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It was reported that the screw was found to be loose.The patient was in pain and revision surgery was performed for replacement of hardware, upsize screws and fuse posterior lateral.
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Manufacturer Narrative
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Visual inspection: the returned screw was inspected and no damage or deformation was observed.Functional inspection: not performed because the event is related to in-vivo performance and therefore functionality could not be duplicated.Dimensional inspection: not performed because there is no indication the event was related to dimensions of the device.Materials analysis: not performed because there is no indication the event was related to materials properties.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was confirmed via x-ray that a screw main body migrated post-operatively.Based on the information received, it was difficult to confirm the number of screws reported to have migrated; conservatively, we deem all reported screws under this event migrated.The root cause for screw migration is due to the unstable construct of the supplemental fixation system secondary to the blocker migration.
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Search Alerts/Recalls
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