VariAx 656320Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327068702), received between Feb 21, 2019 and Aug 3, 2026 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Fracture

  As reported "The Variax 2 plate was implanted on (b)(6) 2025 and fractured outside a medical facility. Subsequent removal and reosteosynthesis took place on (b)(6) 2026."Additionally, upon product return it was identified that one of the screws was also broken.

  Patient problems: Insufficient Information

  MAUDE report 50117582 ↗
• MalfunctionFeb 14, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN THE LOCKING SCREW WAS SCREWED IN, IT SPUN AND HAD NO HOLD IN THE PLATE. WHEN THE DOCTOR ATTEMPTED TO UNSCREW THE SCREW, IT ALSO SPUN AND COULD THEREFORE NOT BE REMOVED. IT REMAINED IN THE PLATE AND THE TREATMENT WAS LEFT AS IT WAS. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13523754 ↗
• MalfunctionFeb 23, 2021Positioning Failure; Positioning Failure

  "IT WAS REPORTED THAT DURING A RIGHT DISTAL RADIUS PLATE IMPLANTATION, SCREWS WOULD NOT LOCK INTO SEVERAL OF THE DISTAL LOCKING HOLES OF THE PLATE. OVERALL, 14 SCREWS WERE WASTED. PLATE WAS SUCCESSFULLY IMPLANTED WITH A SURGICAL DELAY OF APPROXIMATELY 1 HOUR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369638 ↗
• MalfunctionNov 24, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "NO BLOCKING WAS POSSIBLE. REPLACEMENT WAS AVAILABLE. SURGICAL DELAY OF 15MIN. NOT LONGER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10891284 ↗
• MalfunctionOct 22, 2020Fracture; Fracture

  IT WAS REPORTED "THAT DURING THE CASE TWO OF THE 2.7MM (8) CORTEX SCREW HEADS BROKE OFF AT THE HEAD ON TIGHTENING. IT WAS FURTHER REPORTED THAT THE SURGEON DID NOT USE ANY MORE FORCE THAN USUAL." SURGICAL DELAY: APPROXIMATELY 10 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10719811 ↗
• MalfunctionSep 18, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "ANGULAR STABILITY IS FUNCTIONLESS." "CHIPS HAVE COME LOOSE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10557199 ↗
• MalfunctionSep 18, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "ANGULAR STABILITY IS FUNCTIONLESS." "CHIPS HAVE COME LOOSE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10556215 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT MIDFOOT OPEN REDUCTION + INTERNAL FIXATION + LISFRANC STABILISATION. METALOSIS WAS OBSERVED DURING REMOVAL.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 9549213 ↗
• MalfunctionAug 13, 2019Difficult to Remove

  AS REPORTED: "VARIAX SCREWS LOCKED INTO THE PLATE AND WOULD NOT COME OUT" AND "NEEDED TO COMPLETELY REMOVE OUR PRODUCT AND PUT A DIFFERENT PRODUCT IN". ADDITIONALLY REPORTED: "THESE EACH LOCKED INTO THE PLATE BUT WERE SPINNING AS IF THEY WEREN¿T LOCKED. THE HEADS DID NOT STRIP BUT THE SURGEON WAS UNABLE TO BACK THE SCREW OUT FROM THE PLATE, AND HAD TO RIP THE ENTIRE CONSTRUCT OUT AS ONE. THIS WAS THE FIRST CASE WITH THIS PATIENT AND WAS NOT A REVISION SURGERY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8889992 ↗
• MalfunctionAug 13, 2019Difficult to Remove

  AS REPORTED: "VARIAX SCREWS LOCKED INTO THE PLATE AND WOULD NOT COME OUT" AND "NEEDED TO COMPLETELY REMOVE OUR PRODUCT AND PUT A DIFFERENT PRODUCT IN". ADDITIONALLY REPORTED: "THESE EACH LOCKED INTO THE PLATE BUT WERE SPINNING AS IF THEY WEREN¿T LOCKED. THE HEADS DID NOT STRIP BUT THE SURGEON WAS UNABLE TO BACK THE SCREW OUT FROM THE PLATE, AND HAD TO RIP THE ENTIRE CONSTRUCT OUT AS ONE. THIS WAS THE FIRST CASE WITH THIS PATIENT AND WAS NOT A REVISION SURGERY."

  Patient problems: Failure of Implant

  MAUDE report 8889814 ↗
• MalfunctionAug 13, 2019Difficult to Remove; Mechanical Jam

  AS REPORTED: "VARIAX SCREWS LOCKED INTO THE PLATE AND WOULD NOT COME OUT" AND "NEEDED TO COMPLETELY REMOVE OUR PRODUCT AND PUT A DIFFERENT PRODUCT IN." ADDITIONALLY REPORTED: "THESE EACH LOCKED INTO THE PLATE BUT WERE SPINNING AS IF THEY WEREN¿T LOCKED. THE HEADS DID NOT STRIP BUT THE SURGEON WAS UNABLE TO BACK THE SCREW OUT FROM THE PLATE, AND HAD TO RIP THE ENTIRE CONSTRUCT OUT AS ONE. THIS WAS THE FIRST CASE WITH THIS PATIENT AND WAS NOT A REVISION SURGERY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8889802 ↗
• MalfunctionJul 8, 2019Break; Difficult to Remove; Material Twisted/Bent

  UPON FINAL TIGHTENING OF A LOCKING 2.7 X 20 MM VARIAX 2 T8 SCREW INTO A CURVED FOOT PLATE, THE HEAD OF THE SCREW SHEARED OFF. SCREW IS LOCKED IN PLACE BUT WITH NO WAY TO REMOVE. THIS RESULTED IN DIFFICULTY IN ABILITY TO REMOVE SCREW AND PLATE. NO SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8767215 ↗
• MalfunctionApr 16, 2019Connection Problem

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A RIGHT DISTAL RADIUS, THAT TWO OF THE LOCKING SCREWS (A 16 AND A 20) WOULD NOT LOCK INTO THE VARIAX 2 PLATE. THE SCREWS KEPT SPINNING WHEN FULLY IMPLANTED AND COULD NOT BE BACKED OUT. THE SURGEON DECIDED TO LEAVE THE SCREWS IN AS NON-LOCKING SCREWS. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 2 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8520380 ↗
• MalfunctionMar 19, 2019Fitting Problem

  PRIMARY PROCEDURE, RIGHT DISTAL RADIUS. IT WAS REPORTED THAT UPON IMPLANTATION, THE SURGEON REPORTED THE SCREW REFUSED TO LOCK INTO THE PLATE. ANOTHER SCREW WAS IMPLANTED AND LOCKED AS EXPECTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 45 SECONDS. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8434676 ↗
• InjuryFeb 21, 2019Patient-Device Incompatibility

  ALLEGEDLY THE PATIENT UNDERWENT FOOT SURGERY IN (B)(6) 2018 WITH STRYKER COMPONENTS AND SUBSEQUENTLY HAD THE HARDWARE REMOVED IN (B)(6) 2018. PATIENT ALLEGES SHE HAD A REACTION TO THE MATERIAL COMPOSITIONS OF THESE SYSTEMS WHICH RESULTED IN ALLEGED INJURY OF COMPLEX REGIONAL PAIN SYNDROME (CRPS).

  Patient problems: Reaction

  MAUDE report 8359167 ↗