VariAx 656316Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327068689), received between Feb 21, 2019 and Feb 13, 2023 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN IN THE RIGHT FOOT AND IN THE IMPLANT. THE PATIENT HAD HARDWARE REMOVED DUE TO MECHANICAL FAILURE/MALFUNCTION OF FUSION( RIGHT FOOT). THE INITIAL DIAGNOSIS WAS PSEUDARTHROSIS AFTER FUSION OR ARTHRODESIS. THE PRE-OPERATIVE DIAGNOSIS WAS RIGHT HALLUX LIMITUS WITH NON-UNION. NON-UNION HALLUX INTERPHALANGEAL JOINT FUSION. THE PATIENT UNDERWENT REVISION RIGHT FIRST METATARSAL PHALANGEAL JOINT FUSION. RIGHT FOOT HARDWARE REMOVAL. RIGHT HALLUX ARTHROPLASTY. CALCANEAL BONE GRAFT HARVESTING.

  Patient problems: Implant Pain; Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16362823 ↗
• MalfunctionJan 12, 2022Material Fragmentation; Material Fragmentation

  AS REPORTED: "WHEN SCREWING IN THE SCREW, METAL CAME LOOSE ON THE THREAD. A NEW SCREW WAS USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235399 ↗
• MalfunctionJun 2, 2021Positioning Failure; Positioning Failure

  AS REPORTED: "INCIDENT THAT HAS OCCURRED ON 5 OCCASIONS IN THE TRAUMATOLOGICAL HOSPITAL CORRESPONDING TO THE SURGERIES THAT WE HAVE TENDERED WITH THE RADIO DISTAL VARIAX PLATE THE SPECIFIC PROBLEM IS THAT WHEN THE SCREW 2.7 IS PLACED IN THE OVAL HOLE OF THE PLATE, IT ROLLS, DOES NOT TIGHTEN, IT BECOMES LOOSE, ALTHOUGH THE LENGTH OF THE SCREW HAS BEEN CHANGED SEVERAL TIMES. THE SCREW BOX WAS REVIEWED BY CHECKING THE SCREW HEAD, CHANGING THE SCREWDRIVER, TALKING AND OBSERVING WITH THE ASSISTANTS AND DOCTORS ABOUT THE TECHNIQUE USED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11926341 ↗
• 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 11369641 ↗
• 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 11369640 ↗
• 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 11369634 ↗
• InjuryOct 9, 2020Fracture; Fracture

  AS REPORTED: "ORIGINAL CASE WAS FOR A BUNION DEFORMITY, WHERE A LAPIDUS PROCEDURE WAS PERFORMED (B)(6) 2019. DISSECTION, JOINT PREPARATION, AND FIXATION DURING THE CASE WENT FLAWLESS. NO CONCERNS ON DAY OF THE CASE. THE PATIENT PRESENTED 4-6 WEEKS OUT WITH POSSIBLE NON UNION. UPON THE NEXT XRAYS TAKEN, A NON UNION WAS SHOWN, AND A FEW SCREWS USED THROUGH THE PLATE WERE BROKEN FROM THE MOVEMENTS AND INSTABILITY CAUSED BY THE NON UNION AT THE FUSION SITE." DATE OF EXPLANT REPORTED: (B)(6) 2020.

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

  MAUDE report 10657720 ↗
• MalfunctionMar 2, 2020Material Fragmentation; Difficult to Insert; Material Fragmentation; Difficult to Insert

  THE SURGEON WAS USING A VARIAX2 DR IMPLANT KIT TOGETHER WITH AN ORDINARY INSTRUMENT KIT. WHEN INSERTING A LOCKING SCREW, HE EXPERIENCED THAT THE SCREW WOULD NOT ENGAGE IN THE PLATE AND SOME METAL CHIPS WERE DETECTED. THEY KEPT THE PLATE IN PLACE AND USED OTHER SCREWS IN THE PLATE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9775873 ↗
• MalfunctionAug 5, 2019Positioning Problem

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE FOR A LEFT DISTAL RADIUS FRACTURE, THE LOCKING SCREW WOULD NOT LOCK, AND KEPT SPINNING IN THE PLATE. ANOTHER SCREW WAS USED AND LOCKED AS INTENDED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN FIVE MINUTES. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8862800 ↗
• MalfunctionJul 31, 2019Difficult to Insert; Difficult to Insert; Defective Device

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A RIGHT DISTAL RADIUS, AFTER PRE-DRILLING HOLES, THE FIRST LOCKING SCREW WAS PLACED AND WOULD NOT LOCK. THE SCREW JUST KEPT SPINNING IN THE PLATE. A SECOND SCREW WAS USED IN THE SAME HOLE AND LOCKED AS INTENDED. THIS SAME EXPERIENCE (FIRST SCREW NOT LOCKING, SECOND SCREW LOCKING) HAPPENED ON ADDITIONAL HOLES. SURGERY WAS COMPLETED SUCCESSFULLY WITH AN APPROXIMATE ONE MINUTE DELAY AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8848094 ↗
• MalfunctionApr 16, 2019Defective Device

  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 8520379 ↗
• InjuryFeb 21, 2019Patient-Device Incompatibility

  ALLEGEDLY THE PATIENT UNDERWENT FOOT SURGERY IN (B)(6) OF 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 8359161 ↗