VARIAX 628227SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540687135), received between Dec 6, 2018 and Nov 10, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionNov 10, 2025Positioning Failure; Malposition of Device; Positioning Failure; Malposition of Device

  AS REPORTED: "VARIAX SUPERIOR LATERAL PLATE WAS USED AND THE LOCKING SCREW WAS NOT LOCKING IN THE DISTAL HOLE. (2 LOCATIONS)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509761 ↗
• InjuryOct 14, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "A REVISION SURGERY IS PERFORMED FOR PATIENT WHO UNDERWENT INITIAL SURGERY APPROXIMATELY TWO MONTHS EARLIER BECAUSE OF A PLATE FRACTURE."

  Patient problems: Failure of Implant

  MAUDE report 15604915 ↗
• InjuryJun 17, 2020Fracture; Fracture

  AS REPORTED: "AT (B)(6) HOSPITAL, THE FIRST OPERATION WAS PERFORMED ON (B)(6) 2019 USING 7 HOLES OF VARIAX CLAVICLE SUPERIOR LATERAL PLATE. THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS, BUT IN (B)(6) 2020, THE PATIENT PICKED UP A HEAVY OBJECT DURING WORK AND FELT DISCOMFORT IN THE CLAVICLE AND VISITED A HOSPITAL. AS A RESULT OF THE MEDICAL EXAMINATION, BREAKAGE OF THE PLATE WAS CONFIRMED. THE REVISION WAS SCHEDULED FOR (B)(6), BUT IT WAS CANCELED DUE TO THE IMPACT OF COVID 19. ON (B)(6), AT (B)(6) HOSPITAL, A NON-UNION WAS CONFIRMED AND REVISION SURGERY WAS PERFORMED USING A PLATE."

  Patient problems: Failure of Implant; Injury; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10165265 ↗
• InjuryDec 6, 2018Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED THAT THE ORIF WAS DONE WITH VARIAX CLAVICLE PLATE AT (B)(6) 2017. OVER ONE YEAR AFTER OPERATION, HE FRACTURED AGAIN WHEN HE SUPPORTED 750CC BIKE. THE PLATE WAS BENT TO 45 DEGREE AND SCREWS BACK OUT AND BROKEN WAS NOT OCCURRED. ALL DEVICES WERE REMOVED AND REDUCE FRACTURE BONE AND THE PLATE WAS RE-IMPLANTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 8139807 ↗