VariAx 656418Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327068955), received between Mar 27, 2019 and Jun 30, 2023 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Break; Fracture; Break; Fracture

  AS REPORTED : "SCREW HEAD BROKEN. OBVIOUS DEFECT. MATERIAL CONSEQUENCES: TIME LOST + MATERIAL LOST. FOR THE PATIENT: REAL LEVEL OF SERIOUSNESS." ADDITIONAL INFORMATION: "A SCREW BROKE WHEN TIGHTENED WITH THE SCREWDRIVER SUPPLIED WITH THE SCREWS. THE THREADED PART REMAINED IN THE PATIENT'S BONE, AND AN ADDITIONAL SCREW WAS POSITIONED IN AN ADJACENT HOLE IN THE PLATE."

  Patient problems: Foreign Body In Patient

  MAUDE report 17236373 ↗
• 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 10657722 ↗
• MalfunctionAug 11, 2020Fracture; Fracture

  AS REPORTED: "SCREW HEAD BROKE OFF."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10393855 ↗
• MalfunctionJul 15, 2020Positioning Failure; Positioning Failure

  THE "VARIAX 2 LOCKING SCREWS T10 2.7" DID NOT LOCK INTO THE PLATE. NEW SCREWS WERE USED TO COMPLETE THE SURGERY SUCCESSFULLY. SURGICAL DELAY OF 15MIN. NOT LONGER.

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

  MAUDE report 10277943 ↗
• MalfunctionJul 15, 2020Positioning Failure; Positioning Failure

  THE "VARIAX 2 LOCKING SCREWS T10 2.7" DID NOT LOCK INTO THE PLATE. NEW SCREWS WERE USED TO COMPLETE THE SURGERY SUCCESSFULLY. SURGICAL DELAY OF 15MIN. NOT LONGER.

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

  MAUDE report 10277934 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPEN REDUCTION AND INTERNAL FIXATION OF THE LEFT MIDFOOT. METALOSIS WAS OBSERVED DURING REMOVAL.

  Patient problems: Injury; Reaction

  MAUDE report 9549315 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPEN REDUCTION AND INTERNAL FIXATION OF THE LEFT MIDFOOT. METALLOSIS WAS OBSERVED DURING REMOVAL.

  Patient problems: Injury; Reaction

  MAUDE report 9549222 ↗
• 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. METALLOSIS WAS OBSERVED DURING REMOVAL.

  Patient problems: Injury; Reaction

  MAUDE report 9549212 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VARIAX FOOT PLATE METALOSIS NOTICED UPON REMOVAL ON (B)(6) 2019 BY SURGEON. IMPLANTED ON 5(B)(6) 2019. REMOVAL NOT FOR NON-UNION, JUST REMOVAL OF METALWARE.

  Patient problems: Injury; Reaction

  MAUDE report 9549103 ↗
• MalfunctionJul 29, 2019Break

  CUSTOMER REPORTED THAT : "WRIST OSTEOSYNTHESIS BY PLATE AND SCREWS (VARIAX - STRYKER). SCREW HEAD BROKEN ON THE SCREWDRIVER BIT PROVIDED FOR THIS PURPOSE, ONCE THE SCREW HAS BEEN FULLY INSERTED. SCREW DRIVER BIT NO LONGER USABLE, SCREWDRIVER CHANGE. IF THE NECESSARY MATERIAL IS REMOVED, THE SCREW WILL BE DIFFICULT OR IMPOSSIBLE TO REMOVE, MAKING IT DIFFICULT TO REMOVE THE PLATE." BROKEN SCREWDRIVER WAS REPORTED UNDER (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8839582 ↗
• MalfunctionMar 27, 2019Break

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A LEFT DISTAL RADIUS, WHEN SEATING THE NON-LOCKING SCREW, THE HEAD BROKE OFF JUST AS IT WAS FULLY SEATING. THE SCREW SHAFT WAS LEFT IN THE PATIENT AND SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF LESS THAN ONE MINUTE. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8457928 ↗