VARIAX 628008SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540686879), received between Dec 3, 2018 and Mar 30, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  THE SURGEON GAVE PERMISSION TO MOVE, BUT CARRYING HEAVY OBJECTS WAS PROHIBITED. THE BONE HAD NOT HEALED, AND THE PATIENT DID NOT FOLLOW THE POSTOPERATIVE INSTRUCTIONS GIVEN BY THE PHYSICIAN AND CARRIED HEAVY OBJECTS. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN, AND IT WAS FOUND THAT THE DISTAL SCREW HAD DISENGAGED. NON-UNION WAS NOTICED. THE FOLLOWING SCREWS WERE REPORTED: (b)(6). IT WAS REPORTED THAT THEY WERE UNABLE TO DETERMINE WHICH SCREW WAS LOOSE. HOWEVER, IT WAS REPORTEDLY THE DISTAL SCREW, ALTHOUGH IT IS UNKNOWN WHICH SPECIFIC SCREW. AS A RESULT, A REVISION PROCEDURE WAS PERFORMED TO REPLACE THE PLATE AND THE SCREWS.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 24710461 ↗
• InjuryAug 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE MOST MEDIAL SCREW LOOSENED FROM 3 WEEKS AFTER THE OPERATION, AND FINALLY THE LOCK WAS RELEASED AND ALL THE IMPLANTS CAME OFF. ON (B)(6) 2021, REVISION SURGERY WAS PERFORMED AND IT WAS REPLACED WITH A LONG PLATE.

  Patient problems: Failure of Implant

  MAUDE report 12318002 ↗
• MalfunctionAug 4, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN USING THE VARIAX LOCKING SCREW, THE PLATE AND SCREW DID NOT LOCK." ADDITIONALLY REPORTED: "ONLY ONE HOLE IN THE PLATE COULD NOT BE LOCKED. THE PROCEDURE ENDED WITHOUT INSERTING A SCREW INTO THE HOLE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10365319 ↗
• InjuryDec 3, 2018Device Dislodged or Dislocated

  POSTOPERATIVE, IMPLANTED SCREW WAS BACKOUT . AS PRIMARY PROCEDURE, IMPLANTED THE FIRST 8 HOLE SUPERIOR ROW BEND PLATE, BUT REPLACES USING SUPERIOR LOW BEND 10 HOLES AS REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 8126112 ↗