VARIAX 657318SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327086904), received between Nov 19, 2019 and Jul 1, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2025Migration; Migration

  AS REPORTED: "PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2025. TWO MONTHS AFTER SURGERY, AN X-RAY REVEALED THAT THE 2 LOCKING SCREWS INSERTED ON THE OUTSIDE PLATE HAD BACKED OUT OF THE PLATE AND THE LOCK HAD COME LOOSE. THE SCREWS INSERTED INTO THE FIRST AND THIRD HOLES FROM THE OUTER SIDE OF THE PLATE BACKED OUT. IT IS UNCLEAR WHICH OF THE SCREWS ACTUALLY BACKED OUT. THE PATIENT IS ORIGINALLY A FARMER AND, ACCORDING TO REPORTS, RESUMED WORK THREE WEEKS AFTER SURGERY WITHOUT FOLLOWING THE DOCTOR'S INSTRUCTIONS. REVISION SURGERY IS SCHEDULED ON (B)(6) 2025".

  Patient problems: Insufficient Information

  MAUDE report 22378067 ↗
• MalfunctionJul 9, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "DID NOT LOCK INTO PLATE. IT WAS REPLACED BY ANOTHER SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19699850 ↗
• MalfunctionApr 26, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "ORIF WAS PERFORMED FOR A MALE PATIENT WITH FIBULA FRACTURE. DURING SURGERY, TWO LOCKING SCREW HAD TO BE REPLACED DUE TO LOCKING FAILURE DURING INSERTION. FINALLY IT WAS SUCCESSFULLY LOCKED BY USING THE THIRD LOCKING SCREW AND THE SURGERY WAS COMPLETED WITHOUT PROBLEM. NO ADVERSE EVENTS OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197860 ↗
• MalfunctionMar 2, 2023Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "WIRE-LIKE SHAVINGS WERE PRODUCED DURING INSERTION OF THE SCREW. SINCE THE SCREW DID NOT LOCK, A NEW SCREW WAS REPLACED AND THE OPERATION WAS TERMINATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16474005 ↗
• InjuryApr 29, 2022Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THERE WAS SCREW LOOSENING AND POOR FIXATION WAS DISCOVERED. THEREFORE, ALL THE IMPLANTS WERE EXTRACTED.

  Patient problems: Insufficient Information

  MAUDE report 14251331 ↗
• MalfunctionApr 8, 2022Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "THE LOCKING SCREW CONTINUED TO TURN WITHOUT LOCKING. ONCE THE SCREW WAS REMOVED, A DEBRIS WAS FOUND. OTHER SCREW WAS USED AFTER THAT AND THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEMS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14060080 ↗
• MalfunctionApr 16, 2021Positioning Failure; Positioning Failure

  AS REPORTED: "LOCKING SCREW DID NOT LOCK DURING THE OPERATION FOR CLAVICLE(RIGHT SIDE) . THE SURGEON'S VIEW FOR THE CAUSE WAS UNKNOWN. IT MAY BE TOO ANGLED, BUT THE REPORTING SR THOUGHT IT WAS WITHIN THE ACCEPTABLE RANGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11678438 ↗
• MalfunctionSep 28, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "[EVENT DETAILS] WHEN THE CLAVICLE HOOK PLATE WAS OPERATED, THE LOCKING SCREW DID NOT LOCK IN THE LOCKING HOLE. PLATE USED: 628535S LOCATION OF DEFECTIVE LOCK: FRONT SIDE OF THE PLATE'S MOST DISTAL HOLE OCCURRENCE STATUS: - INSERT 3 SCREWS AFTER SETTING THE PLATE ((1) ELLIPTICAL HOLE: NON-LOCKING, (2) ROUND HOLE NEXT TO THE ELLIPSE DISTAL SIDE: ROCKING, (4) FAR-MOST REAR CIRCULAR HOLE: ROCKING) - A PHENOMENON THAT THE LOCKING SCREW DOES NOT LOCK WHEN THE LOCKING SCREW IS INSERTED 18MM INTO THE 4TH MOST DISTAL LOCKING HOLE - SET IT THERE AND INSERT THE LOCKING SCREW INTO THE MOST RECENT HOLE (LOCK WITHOUT ANY PROBLEM) - I TRIED THE FOLLOWING FOR HOLES THAT DID NOT LOCK AGAIN - CHECK THE DRILLING DIRECTION ¿ NO PROBLEM (THE GUIDE SLEEVE WAS WITHIN THE SWING RANGE) - CONFIRMATION OF PLATE LIP AND SCREW HEAD ¿ NO INTERSTITIAL TISSUE SUCH AS SOFT TISSUE CAN BE CONFIRMED ON THE LIP. AS FAR AS I COULD SEE THE SCREW HEAD, IT SEEMED TO BE NO PROBLEM. - CHANGE THE DRILL DIRECTION AND INSERT ANOTHER LOCKING SCREW 16 MM AGAIN, BUT IT DOES NOT LOCK - FINALLY, AT THE DISCRETION OF DR., IT ENDS WITHOUT INSERTING A SCREW INTO THE HOLE." "THE PLATE IS CURRENTLY INSIDE THE PATIENT'S BOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10597565 ↗
• MalfunctionApr 8, 2020Difficult to Insert; Difficult to Insert

  AS REPORTED, THE LOCKING SCREW DID NOT LOCK WHEN THE LOCKING SCREW WAS INSERTED INTO THE PLATE. I CHECKED THE INSERTION ANGLE AND THE DEPTH OF THE DRILL, AND REINSERTED IT SEVERAL TIMES, BUT DID NOT LOCK. I CHANGED IT TO A SCREW OF THE SAME SIZE AND LOCKED IT WHEN I PUT IT BACK IN. DOCTOR'S VIEW: "IS THE SCREW DEFECTIVE, THE PLATE DEFECTIVE, OR THE SCREW TOO TIGHT?" (B)(4) COMMENT, "IT IS POSSIBLE THAT THE SCREW HAS CONTACTED HARD BONE AND CHANGED THE ANGLE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9936221 ↗
• MalfunctionNov 19, 2019Material Erosion; Material Fragmentation; Material Erosion; Material Fragmentation

  VARIAX CLAVICLE OPERATION. WHEN THE LOCKING SCREW WAS INSERTED, A THREAD-LIKE METAL PIECE CAME OUT FROM BETWEEN THE PLATE AND THE SCREW. REPLACED WITH A NEW LOCKING SCREW OF THE SAME SIZE. THE OPERATION ENDED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9345730 ↗