VARIAX 657314SRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07613327086850), received between Sep 27, 2019 and Mar 25, 2026 — classified as 7 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (12 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Positioning Failure

  AS REPORTED: "PLATE AND LOCKING SCREW LOCKING FAILURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691599 ↗
• MalfunctionNov 10, 2025Positioning Failure; Positioning Failure

  AS REPORTED: "VARIAX SUPERIOR LATERAL PLATE WAS USED AND THE LOCKING SCREW WAS NOT LOCKING IN THE DISTAL HOLE. (2 LOCATIONS)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509762 ↗
• 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 22378037 ↗
• MalfunctionFeb 21, 2025Material Fragmentation; Material Fragmentation

  AS REPORTED: "WHEN THE LOCKING SCREW WAS INSERTED AS USUAL, METAL FRAGMENTS CAME OUT DURING LOCKING. JUST TO BE SURE, THE SCREW WAS REPLACED AND THE PROBLEM WAS RESOLVED".

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439700 ↗
• MalfunctionJan 9, 2025Positioning Failure; Material Fragmentation; Device Difficult to Setup or Prepare; Material Deformation; Positioning Failure; Material Fragmentation; Device Difficult to Setup or Prepare; Material Deformation

  IT WAS REPORTED: DURING SCREW INSERTION, THE SCREW HEAD THREAD WAS SHAVED DUE TO AN INSERTION ANGLE PROBLEM, RESULTING IN POOR LOCKING, AND ANOTHER SCREW WAS OPENED AND USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120459 ↗
• MalfunctionDec 4, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "THE 3.5 MM DIAMETER 14 MM LOCKING SCREW OF THE VARIAXS CLAVICLE REPORTED DID NOT LOCK, SO IT WAS REPLACED WITH ANOTHER SCREW AND NEW SCREW LOCKED WITHOUT PROBLEM. THE SUBJECT SCREW DID NOT LOCK IN THE OTHER HOLE THOUGH THE ANGLE INSERTED WAS WITHIN 15 DEGREES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20849753 ↗
• MalfunctionOct 21, 2024Positioning Failure; Positioning Failure

  THE LOCKING SCREW COULD NOT BE LOCKED TO THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494931 ↗
• MalfunctionSep 25, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED, WHEN THE LOCKING SCREW WAS USED, THE LOCKING SCREW WAS NOT ENGAGED IN THE LIP OF THE PLATE AND COULD NOT BE LOCKED. A NEW SCREW WAS USED TO FIX THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306099 ↗
• MalfunctionApr 8, 2024Material Fragmentation; Unraveled Material; Material Fragmentation; Unraveled Material

  AS REPORTED: "ORIF WAS PERFORMED FOR LEFT DISTAL FIBULA FRACTURE (PRIMARY SURGERY DATE IS UNKNOWN). DURING THE BARIATRIC FIBULA EXPLANTING SURGERY ON (B)(6) 2024, SOMETHING LIKE METAL SHAVINGS CAME OUT WHILE REMOVING THE BONE SURROUNDING THE SCREW HEAD." NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068007 ↗
• MalfunctionFeb 20, 2024Positioning Problem; Positioning Problem

  AS REPORTED: "LOCKING SCREW DID NOT LOCK WITH PLATE, OPENED AND USED A NEW DIFFERENT PRODUCT AND SUCCESSFULLY LOCKED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743742 ↗
• MalfunctionFeb 6, 2024Positioning Problem; Positioning Problem

  AS REPORTED: "PLATE FIXATION USING VARIAX FIBULA FOR RIGHT FIBULA FRACTURE. DURING THE SURGERY, THE SCREW LOCKING FAILED. THE SCREW WAS REPLACED WITH ANOTHER ONE (DIFFERENT SIZE), AND THE NEW SCREW COULD BE USED WITHOUT PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18655476 ↗
• MalfunctionJan 2, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED: "DURING THE INSTALLATION OF A LOCKED SCREW ON A PLATE, A STEEL WIRE CAME LOOSE. THE WIRE PRICKED THE SURGEON'S FINGER."

  Patient problems: Needle Stick/Puncture

  MAUDE report 18424445 ↗
• InjuryNov 28, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT HAD PRIMARY SURGERY AND A FIBULAR PLATE AND SCREWS WERE INSERTED. THE PLATE AND SCREWS WERE EXTRACTED ON (B)(6) 2022 DUE TO COMPLETED BONE UNION. ON (B)(6) 2023 THE PATIENT WAS SEEN IN THE OUTPATIENT CLINIC BECAUSE OF THE APPEARANCE OF AN INFLAMMATORY REACTION. THE AFFECTED AREA HAD STARTED TO SWELL A LITTLE AROUND JANUARY AND THEN THE BULGE IN THE AFFECTED AREA GREW LARGER. A METAL SHARD-LIKE SUBSTANCE WAS REMOVED FROM THE SURGICAL WOUND THROUGH A SMALL INCISION.

  Patient problems: Failure of Implant; Foreign Body In Patient; Inflammation; Swelling/ Edema

  MAUDE report 18219260 ↗
• InjuryNov 28, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT HAD PRIMARY SURGERY AND A FIBULAR PLATE AND SCREWS WERE INSERTED. THE PLATE AND SCREWS WERE EXTRACTED ON (B)(6) 2022 DUE TO COMPLETED BONE UNION. ON (B)(6) 2023 THE PATIENT WAS SEEN IN THE OUTPATIENT CLINIC BECAUSE OF THE APPEARANCE OF AN INFLAMMATORY REACTION. THE AFFECTED AREA HAD STARTED TO SWELL A LITTLE AROUND JANUARY AND THEN THE BULGE IN THE AFFECTED AREA GREW LARGER. A METAL SHARD-LIKE SUBSTANCE WAS REMOVED FROM THE SURGICAL WOUND THROUGH A SMALL INCISION.

  Patient problems: Failure of Implant; Foreign Body In Patient; Inflammation; Swelling/ Edema

  MAUDE report 18219248 ↗
• InjuryNov 28, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON 28 APR 2021 THE PATIENT HAD PRIMARY SURGERY AND A FIBULAR PLATE AND SCREWS WERE INSERTED. THE PLATE AND SCREWS WERE EXTRACTED ON 01 JUN 2022 DUE TO COMPLETED BONE UNION. ON (B)(6) 2023 THE PATIENT WAS SEEN IN THE OUTPATIENT CLINIC BECAUSE OF THE APPEARANCE OF AN INFLAMMATORY REACTION. THE AFFECTED AREA HAD STARTED TO SWELL A LITTLE AROUND JANUARY AND THEN THE BULGE IN THE AFFECTED AREA GREW LARGER. A METAL SHARD-LIKE SUBSTANCE WAS REMOVED FROM THE SURGICAL WOUND THROUGH A SMALL INCISION.

  Patient problems: Failure of Implant; Foreign Body In Patient; Inflammation; Swelling/ Edema

  MAUDE report 18219247 ↗
• MalfunctionAug 17, 2023Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  AS REPORTED: "WHEN THE SCREW WAS INSERTED, THE DOCTOR FELT LIKE THE SCREW HEAD GOT STRIPPED. THUS, THE DOCTOR STOPPED INSERTING THE SCREW, AND THE PROCEDURE WAS CONTINUED TO REPLACE THE SCREW WITH NEW ONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564603 ↗
• MalfunctionJun 12, 2023Contamination /Decontamination Problem; Mechanical Jam; Contamination /Decontamination Problem; Mechanical Jam

  AS REPORTED: "WHEN REMOVING THE SCREW FROM THE CASE WITH A FORCEPS, THE SCREW WAS STUCK TO THE CASE AND COULD NOT BE REMOVED EASILY. THE SCREW POPPED OUT IN REACTION TO BEING TAKEN OUT AND BECAME UNCLEAN." AN ADDITIONAL SCREW WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105569 ↗
• MalfunctionApr 3, 2023Material Fragmentation; Appropriate Device Problem Term/Code Not Available; Material Fragmentation; Appropriate Device Problem Term/Code Not Available

  AS REPORTED, "ORIF WAS PERFORMED FOR ANKLE FRACTURE USING VARIAX 2 FIBULA PLATE AND ASNIS 4.0MM. X-RAY TAKEN AFTER THE PLATED WAS PLACED TO THE TARGET SITE REVEALED THAT THERE WAS WHAT APPEARED TO BE A PIECE OF METAL AT THE SITE. THE METAL PIECE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16667363 ↗
• MalfunctionSep 30, 2022Break; Positioning Failure; Fracture; Break; Positioning Failure; Fracture

  IT WAS REPORTED THAT A SCREW DID NOT LOCK TO PLATE. WHEN IT WAS REMOVED, THE HEAD BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15518707 ↗
• MalfunctionJul 22, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "THE SCREW DID NOT LOCK TO THE PLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085510 ↗
• 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 14251461 ↗
• 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 14251460 ↗
• 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 14251330 ↗
• MalfunctionDec 20, 2021Positioning Failure; Positioning Failure

  AS REPORTED: "THE SUBJECT SCREW DID NOT LOCK IN THE MOST DISTAL HOLE. ATTEMPTS WERE MADE IN OTHER HOLES, BUT NO LOCKING OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13049454 ↗
• MalfunctionJul 12, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THE SCREW HAD A LOCKING FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12150498 ↗