VARIAX 657312Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613327086812), received between Sep 19, 2018 and Aug 4, 2025 — classified as 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2025Biocompatibility; Biocompatibility

  AS REPORTED: "SURGEON ADVISED HE WAS REMOVING ONE OF OUR VARIAX FIBULA PLATES THAT HE HAD IMPLANTED 5 YEARS PRIOR & AT THE PLATE BONE INTERFACE AS PER ATTACHED PHOTO THERE WAS "GROSS METALLOSIS" AND "PRETTY BAD BONE EROSION" PLATE AND SCREWS HAVE BEEN SUCCESSFULLY REMOVED & WILL BE RETURNED ONCE DECONTAMINATED. SWABS HAVE BEEN SENT TO LOCAL PATHOLOGY."

  Patient problems: Erosion; Foreign Body Reaction

  MAUDE report 22701631 ↗
• InjuryAug 4, 2025Biocompatibility; Biocompatibility

  AS REPORTED: "SURGEON ADVISED HE WAS REMOVING ONE OF OUR VARIAX FIBULA PLATES THAT HE HAD IMPLANTED 5 YEARS PRIOR & AT THE PLATE BONE INTERFACE AS PER ATTACHED PHOTO THERE WAS "GROSS METALLOSIS" AND "PRETTY BAD BONE EROSION" PLATE AND SCREWS HAVE BEEN SUCCESSFULLY REMOVED & WILL BE RETURNED ONCE DECONTAMINATED. SWABS HAVE BEEN SENT TO LOCAL PATHOLOGY."

  Patient problems: Erosion; Foreign Body Reaction

  MAUDE report 22700659 ↗
• InjuryAug 4, 2025Biocompatibility; Biocompatibility

  AS REPORTED: "SURGEON ADVISED HE WAS REMOVING ONE OF OUR VARIAX FIBULA PLATES THAT HE HAD IMPLANTED 5 YEARS PRIOR & AT THE PLATE BONE INTERFACE AS PER ATTACHED PHOTO THERE WAS "GROSS METALLOSIS" AND "PRETTY BAD BONE EROSION" PLATE AND SCREWS HAVE BEEN SUCCESSFULLY REMOVED & WILL BE RETURNED ONCE DECONTAMINATED. SWABS HAVE BEEN SENT TO LOCAL PATHOLOGY."

  Patient problems: Erosion; Foreign Body Reaction

  MAUDE report 22700655 ↗
• InjuryJul 9, 2025Biocompatibility; Biocompatibility

  AS REPORTED: "SURGEON ADVISED HE WAS REMOVING ONE OF OUR VARIAX FIBULA PLATES THAT HE HAD IMPLANTED 5 YEARS PRIOR & AT THE PLATE BONE INTERFACE AS PER ATTACHED PHOTO THERE WAS "GROSS METALLOSIS" AND "PRETTY BAD BONE EROSION" PLATE AND SCREWS HAVE BEEN SUCCESSFULLY REMOVED & WILL BE RETURNED ONCE DECONTAMINATED. SWABS HAVE BEEN SENT TO LOCAL PATHOLOGY."

  Patient problems: Erosion; Foreign Body Reaction

  MAUDE report 22456789 ↗
• MalfunctionNov 15, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS METAL DEBRIS AFTER REMOVING THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15797320 ↗
• MalfunctionNov 15, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS METAL DEBRIS AFTER REMOVING THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796238 ↗
• MalfunctionNov 15, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS METAL DEBRIS AFTER REMOVING THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796153 ↗
• MalfunctionSep 7, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "COULD NOT BE LOCKED WITH LOCKING SCREW ADDITIONAL INFORMATION VARIAX DISTAL FIBRA PLATE 77MM/3 HOLES AND LOCKING SCREW DID NOT LOCK AND THE PROCEDURE WAS CONTINUED USING ANOTHER SCREW OF THE SAME SIZE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369537 ↗
• MalfunctionApr 15, 2021Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "SURGEON WAS USING THE VARIAX 2 SMALL FRAG AND VARIAX 2 CORE TRAY FOR AN ANKLE FRACTURE. THE SURGEON USED PROPER TECHNIQUE IN REGARDS TO USING THE DRILL SLEEVE AND STAYED WITHIN THE 30 DEGREE CONE THAT THE 40-20905 FIBULA PLATE WARRANTS. UPON INSERTING A 657016 LOCKING SCREW, IT DID NOT ENGAGE THE LOCKING MECHANISM. THE SURGEON REMOVED THE SCREW AND USED A FRESH/ NEW 657016 SCREW IN THE SAME SCREW HOLE AND THE SCREW ENGAGED THE PLATE AND LOCKING WAS SUCCESSFUL. LATER ON IN THE CASE, HE ATTEMPTED TO ENGAGE (3) 657312 LOCKING SCREWS INTO THE SAME 40-20905 PLATE WITH THE SAME APPROPRIATE TECHNIQUE AND THOSE SCREWS ALSO DID NOT ENGAGE/LOCK INTO THE PLATE SUCCESSFULLY AND THERE WAS ALSO METAL SHAVINGS THAT APPEARED AFTER THE REMOVAL OF THE SCREWS. THE METAL SHAVINGS ARE NOT KNOWN IF THEY CAME FROM THE SCREWS OR THE FIBULA PLATE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670093 ↗
• MalfunctionApr 15, 2021Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "SURGEON WAS USING THE VARIAX 2 SMALL FRAG AND VARIAX 2 CORE TRAY FOR AN ANKLE FRACTURE. THE SURGEON USED PROPER TECHNIQUE IN REGARDS TO USING THE DRILL SLEEVE AND STAYED WITHIN THE 30 DEGREE CONE THAT THE 40-20905 FIBULA PLATE WARRANTS. UPON INSERTING A 657016 LOCKING SCREW, IT DID NOT ENGAGE THE LOCKING MECHANISM. THE SURGEON REMOVED THE SCREW AND USED A FRESH/ NEW 657016 SCREW IN THE SAME SCREW HOLE AND THE SCREW ENGAGED THE PLATE AND LOCKING WAS SUCCESSFUL. LATER ON IN THE CASE, HE ATTEMPTED TO ENGAGE (3) 657312 LOCKING SCREWS INTO THE SAME 40-20905 PLATE WITH THE SAME APPROPRIATE TECHNIQUE AND THOSE SCREWS ALSO DID NOT ENGAGE/LOCK INTO THE PLATE SUCCESSFULLY AND THERE WAS ALSO METAL SHAVINGS THAT APPEARED AFTER THE REMOVAL OF THE SCREWS. THE METAL SHAVINGS ARE NOT KNOWN IF THEY CAME FROM THE SCREWS OR THE FIBULA PLATE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670092 ↗
• MalfunctionApr 15, 2021Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "SURGEON WAS USING THE VARIAX 2 SMALL FRAG AND VARIAX 2 CORE TRAY FOR AN ANKLE FRACTURE. THE SURGEON USED PROPER TECHNIQUE IN REGARDS TO USING THE DRILL SLEEVE AND STAYED WITHIN THE 30 DEGREE CONE THAT THE 40-20905 FIBULA PLATE WARRANTS. UPON INSERTING A 657016 LOCKING SCREW, IT DID NOT ENGAGE THE LOCKING MECHANISM. THE SURGEON REMOVED THE SCREW AND USED A FRESH/ NEW 657016 SCREW IN THE SAME SCREW HOLE AND THE SCREW ENGAGED THE PLATE AND LOCKING WAS SUCCESSFUL. LATER ON IN THE CASE, HE ATTEMPTED TO ENGAGE (3) 657312 LOCKING SCREWS INTO THE SAME 40-20905 PLATE WITH THE SAME APPROPRIATE TECHNIQUE AND THOSE SCREWS ALSO DID NOT ENGAGE/LOCK INTO THE PLATE SUCCESSFULLY AND THERE WAS ALSO METAL SHAVINGS THAT APPEARED AFTER THE REMOVAL OF THE SCREWS. THE METAL SHAVINGS ARE NOT KNOWN IF THEY CAME FROM THE SCREWS OR THE FIBULA PLATE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670078 ↗
• MalfunctionDec 22, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "NO BLOCKING WAS POSSIBLE - THE PLATE HAD TO BE REMOVED. REPLACEMENT WAS AVAILABLE. SURGICAL DELAY OF 15MIN. NOT LONGER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11060048 ↗
• MalfunctionNov 24, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "NO BLOCKING WAS POSSIBLE - CHIP FORMATION OCCURRED ON THE IMPLANT. REPLACEMENT WAS AVAILABLE. SURGICAL DELAY OF 15MIN. NOT LONGER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10891139 ↗
• InjuryNov 23, 2020Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  AS REPORTED: "A (B)(6)-YEAR-OLD FEMALE PT UNDERWENT THE CLAVICLE JOINT SURGERY (LEFT) ON (B)(6) 2020. AFTER THE OPERATION, THE PLATE MOVED AND THE SCREW CAME OFF THE PLATE, AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020."

  Patient problems: Failure of Implant

  MAUDE report 10887908 ↗
• MalfunctionJul 21, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT TWO OF THE VARIAX 2 LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. THE SCREWS WOULD SEAT, A POP WOULD BE FELT, AND THE SCREW SPINS FREELY. VARIAX 1 LOCKING SCREWS WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10305518 ↗
• MalfunctionJul 21, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT TWO OF THE VARIAX 2 LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. THE SCREWS WOULD SEAT, A POP WOULD BE FELT, AND THE SCREW SPINS FREELY. VARIAX 1 LOCKING SCREWS WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10305503 ↗
• MalfunctionJul 20, 2020Positioning Failure; Positioning Failure

  PRIMARY PROCEDURE, LEFT FIBULA. IT WAS REPORTED THAT THE VARIAX 2 3.5 X 12MM LOCKING SCREW POPPED WHEN SEATED INTO THE PLATE, AND THEN SPUN FREELY INSTEAD OF LOCKING. A VARIAX 1 SCREW WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A DELAY OF LESS THAN A MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10299927 ↗
• MalfunctionJul 9, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED: PRIMARY PROCEDURE, RIGHT FIBULA PLATE. IT WAS REPORTED THAT WHEN THE 10MM AND 12MM SCREWS WERE SEATED INTO THE PLATE AND MODERATE TORQUE APPLIED, THE SCREWS KEPT SPINNING IN THE PLATE. THE SCREWS WERE REMOVED AND VARIAX 1 SCREWS WERE USED. THE VARIAX 1 SCREWS DID LOCK INTO THE PLATE AS EXPECTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10253472 ↗
• MalfunctionJul 9, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED: PRIMARY PROCEDURE, RIGHT FIBULA PLATE. IT WAS REPORTED THAT WHEN THE 10MM AND 12MM SCREWS WERE SEATED INTO THE PLATE AND MODERATE TORQUE APPLIED, THE SCREWS KEPT SPINNING IN THE PLATE. THE SCREWS WERE REMOVED AND VARIAX 1 SCREWS WERE USED. THE VARIAX 1 SCREWS DID LOCK INTO THE PLATE AS EXPECTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10253444 ↗
• InjuryJul 29, 2019Detachment of Device or Device Component

  CLAVICLE REVISION CASE; REVISION WAS DUE TO PREVIOUS PLATE AND SCREWS PULLING OUT FROM BONE. SURGEON BELIEVES THIS WAS DUE TO THE PATIENT 'LIFTING WEIGHTS' IN THE GYM EARLIER THAN ADVISED AFTER SURGERY. REVISION CASE WENT ACCORDING TO PLAN WITH NO ISSUES ENCOUNTERED. PATIENT WAS COMPLIANT AND IN A SLING FOR 2 MONTHS. PATIENT IS ALSO A HEAVY SMOKER AND WENT BACK TO WORK AS A CONCRETER AFTER 2 MONTHS POST CASE.

  Patient problems: No Code Available

  MAUDE report 8839434 ↗
• MalfunctionSep 19, 2018Mechanical Problem

  PRIMARY PROCEDURE, RIGHT CLAVICLE. IT WAS REPORTED THAT IN IMPLANTING THE VARIAX2 CORE 3.5 LOCKING SCREWS INTO THE CLAVICULAR PLATE, THE SCREWS WOULD NOT LOCK - THEY KEPT SPINNING WHEN THEY SHOULD HAVE LOCKED. REP OBTAINED LOCKING SCREWS FROM A VARIAX 1 ANKLE SOLUTION SET, WHICH LOCKED AS EXPECTED. THE PLATE IS IMPLANTED AND THE REPORTED SCREWS ARE AVAILABLE FOR RETURN. REP REPORTED THAT SURGEON WAS FOLLOWING THE SURGICAL TECHNIQUE THROUGHOUT THE PROCEDURE. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7891487 ↗