VARIAX 629283SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327082401), received between Apr 30, 2021 and Apr 30, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: "THE PATIENT'S INFECTION, THE SECOND DISTAL SCREW CAME OFF, SO A REVISION OPERATION WAS PERFORMED ON APRIL 5. AFTER THE SKIN WAS CUT, THE SECOND AND THIRD SCREWS THAT HAD ENTERED THE DISTAL AREA WERE REMOVED, WASHED, AND AN ATTEMPT WAS MADE TO INSERT THE SCREW INTO THE SECOND SCREW HOLE AGAIN, BUT THE BONE WAS LOST AND THE INSERTION WAS ABANDONED. SINCE THE SCREW CONTAINED IN THE DISTAL BONE FRAGMENT WOULD DISAPPEAR AS IT IS, I TRIED TO INSERT AT LEAST THE THIRD SCREW FROM THE DISTAL SIDE, AND OPENED AND INSERTED A NEW SCREW SHORTER THAN THE ORIGINALLY INSERTED SCREW, BUT IT DID NOT LOCK. I REINSERTED IT INTO THE HOLE THAT HAD ALREADY BEEN OPENED, BUT IT DID NOT LOCK, SO THIS IS MY REQUEST FOR INVESTIGATION. ALSO, PLEASE CHECK THE PLACE WHERE THE SECOND ONE COMES OUT FROM THE DISTAL SIDE."

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 11753600 ↗