VARIAX 657320SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327086942), received between Apr 4, 2019 and Jul 1, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2025Migration; Migration

  AS REPORTED: "PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2025. TWO MONTHS AFTER SURGERY, AN X-RAY REVEALED THAT THE 2 LOCKING SCREWS INSERTED ON THE OUTSIDE PLATE HAD BACKED OUT OF THE PLATE AND THE LOCK HAD COME LOOSE. THE SCREWS INSERTED INTO THE FIRST AND THIRD HOLES FROM THE OUTER SIDE OF THE PLATE BACKED OUT. IT IS UNCLEAR WHICH OF THE SCREWS ACTUALLY BACKED OUT. THE PATIENT IS ORIGINALLY A FARMER AND, ACCORDING TO REPORTS, RESUMED WORK THREE WEEKS AFTER SURGERY WITHOUT FOLLOWING THE DOCTOR'S INSTRUCTIONS. REVISION SURGERY IS SCHEDULED ON (B)(6) 2025."

  Patient problems: Insufficient Information

  MAUDE report 22378064 ↗
• MalfunctionFeb 10, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "OPEN OSTEOSYNTHESIS WAS PERFORMED FOR RIGHT CLAVICLE. WHEN THE 3.5MM*20MM LOCKING SCREW WAS INSERTED INTO THE SCREW HOLE OF THE PLATE, THE LOCKING FAILURE OCCURRED. THERE WAS NO PARTICULAR PROBLEM WITH THE PROCEDURE UP TO THE INSERTION OF THE SCREW."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353554 ↗
• MalfunctionAug 5, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "LOCKING FAILURE OF LOCKING SCREW AND PLATE." THE PROCEDURE WAS COMPLETED USING ANOTHER AVAILABLE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15174240 ↗
• MalfunctionApr 16, 2021Positioning Failure; Positioning Failure

  AS REPORTED: "THE LOCKING SCREW 20MM DOES NOT LOCK ON VARIAX FIBULA. AFTER THAT, THE SURGEON COULD NOT LOCK THE 20MM THAT WAS OPENED AGAIN. LOCK BY REPLACING SCREW, SIZE BY 16 MM. THE CAUSE OF THE EVENT IS UNKNOWN BECAUSE THE ANGLE OF THE SCREW DID NOT SEEM TO EXCEED THE ACCEPTABLE RANGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11678571 ↗
• MalfunctionApr 15, 2021Positioning Failure; Positioning Failure

  AS REPORTED: "THE LOCKING SCREW 20MM DOES NOT LOCK ON VARIAX FIBULA. AFTER THAT, THE SURGEON COULD NOT LOCK THE 20MM THAT WAS OPENED AGAIN. LOCK BY REPLACING SCREW, SIZE BY 16 MM. THE CAUSE OF THE EVENT IS UNKNOWN BECAUSE THE ANGLE OF THE SCREW DID NOT SEEM TO EXCEED THE ACCEPTABLE RANGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675083 ↗
• MalfunctionNov 24, 2020Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE THREAD ON THE SCREW CAME AWAY AS IT WAS BEING INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10891922 ↗
• MalfunctionMay 13, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "THE LOCKING SCREW DID NOT LOCK. SO, THE SCREW WAS EXCHANGED WITH OTHER LOT ONE AND REINSERTED BUT IT DID NOT LOCK, EITHER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10051948 ↗
• MalfunctionMay 13, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "THE LOCKING SCREW DID NOT LOCK. SO, THE SCREW WAS EXCHANGED WITH OTHER LOT ONE AND REINSERTED BUT IT DID NOT LOCK, EITHER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10051944 ↗
• MalfunctionFeb 10, 2020Migration; Migration

  AS REPORTED: "IN 2006" MAYO PLATE WAS USED FOR NONUNION FRACTURE OF THE DISTAL HUMERUS. ON (B)(6) 2019, MAYO PLATE WAS REMOVED, AND MEDIAL AND LATERAL VARIAX ELBOW PLATE WAS IMPLANTED. TWO WEEKS AFTER REVISION SURGERY, BACK-OUT HAPPENED. (1 PROXIMAL LOCKING SCREW, 2 PROXIMAL CORTICAL SCREW, MOST DISTAL LOCKING SCREW OF LATERAL PLATE)" NO ADDITIONAL SURGERY IS PLANNED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 9690169 ↗
• MalfunctionFeb 10, 2020Migration; Migration

  AS REPORTED: "IN 2006 MAYO PLATE WAS USED FOR NONUNION FRACTURE OF THE DISTAL HUMERUS. ON (B)(6) 2019, MAYO PLATE WAS REMOVED, AND MEDIAL AND LATERAL VARIAX ELBOW PLATE WAS IMPLANTED. TWO WEEKS AFTER REVISION SURGERY, BACK-OUT HAPPENED. (1 PROXIMAL LOCKING SCREW, 2 PROXIMAL CORTICAL SCREW, MOST DISTAL LOCKING SCREW OF LATERAL PLATE)". NO ADDITIONAL SURGERY IS PLANNED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 9690116 ↗
• MalfunctionFeb 10, 2020Migration; Migration

  AS REPORTED: "IN 2006 MAYO PLATE WAS USED FOR NONUNION FRACTURE OF THE DISTAL HUMERUS. ON (B)(6) 2019, MAYO PLATE WAS REMOVED, AND MEDIAL AND LATERAL VARIAX ELBOW PLATE WAS IMPLANTED. TWO WEEKS AFTER REVISION SURGERY, BACK-OUT HAPPENED. (1 PROXIMAL LOCKING SCREW, 2 PROXIMAL CORTICAL SCREW, MOST DISTAL LOCKING SCREW OF LATERAL PLATE)". NO ADDITIONAL SURGERY IS PLANNED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 9690112 ↗
• MalfunctionApr 4, 2019Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT ALTHOUGH THE EXTERIOR VARIAX ELBOW PLATE WAS FIXED WITH LOCKING SCREW, THE SCREW WAS NOT LOCKED. THEREFORE, THE NEW SAME SCREW WAS INSERTED AND THE OPERATION WAS FINISHED. NO SURGICAL DELAY OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8482951 ↗