VARIAX 657312SRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613327086829), received between Sep 16, 2019 and Nov 10, 2025 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 23509760 ↗
• MalfunctionAug 13, 2024Positioning Failure; Positioning Failure

  AS REPORTED : ''THE LOCKING SCREW DID NOT LOCK TO THE PLATE. IT WAS REPLACED TO THE OTHER LOT PRODUCT AND THE PROCEDURE WAS PROGRESSED WITHOUT PROBLEM.''

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978629 ↗
• 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 19068001 ↗
• MalfunctionMar 12, 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 18890810 ↗
• 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 25 OCTOBER 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 18219258 ↗
• 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 (B)(6) 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 18219249 ↗
• 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 (B)(6) 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 18219226 ↗
• MalfunctionJun 30, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "LOCKING FAILURE OF VARIAX FIBULA PLATE LOCKING SCREW WAS HAPPENED. THE SCREW WAS REPLACED AND THE OPERATION COMPLETED WITHOUT PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17236449 ↗
• MalfunctionApr 20, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "THE SCREW DID NOT LOCK TO THE PLATE. OTHER SCREW WAS ABLE TO LOCK TO THE SAME HOLE OF THE PLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14160506 ↗
• MalfunctionNov 16, 2021Migration; Migration

  AS REPORTED: "DURING THE EXTRACTION SURGERY, THE SURGEON NOTICED THAT ONE OF THE LOCKING SCREWS (THIRD FROM THE MEDIAL) HAD LOOSENED."

  Patient problems: Failure of Implant

  MAUDE report 12820952 ↗
• MalfunctionAug 3, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED WHAT WHILE INSERTING THE SCREW, SOMETHING LIKE AN IRON POWDER SUBSTANCE WAS FOUND. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12269733 ↗
• MalfunctionMar 23, 2021Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "DURING THE INITIAL SURGERY ON THE CLAVICLE (LEFT), INSERTED THE SCREW INTO THE PLATE ONCE AND LOCK IT. WHEN THE PULLED OUT THE SCREW TO REPLACE IT WITH ANOTHER ONE, A PIECE OF METAL WAS GENERATED FROM THE SCREW THREAD FOR LOCKING THE SCREW HEAD". NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11553795 ↗
• MalfunctionMay 27, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED: THE LOCKING SCREW DID NOT LOCK TO THE PLATE. ANOTHER NEW SCREW WAS OPENED AND USED WITHOUT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10093211 ↗
• MalfunctionApr 21, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "IN THE VARIAX FIBRA OPERATION THE PROXIMAL SCREW DID NOT LOCK TO THE PLATE. THE SCREW WAS IDLING. THE ANGLE TO THE PLATE WAS NOT STEEP AND THE SCREW OF 12MM WAS INSERTED FOR THE 14MM MEASUREMENT, AND THUS DRILL WAS ENOUGH. THE WOUND WAS CLOSED WITHOUT INSERTING ANOTHER SCREW.".

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

  MAUDE report 9984150 ↗
• MalfunctionFeb 12, 2020Material Fragmentation; Difficult to Insert; Material Fragmentation; Difficult to Insert

  IT WAS REPORTED, WHEN THE LOCKING SCREW WAS INSERTED DURING THE VARIAX FIBULA OPERATION, LOCKING FAILURE OCCURRED. IT SEEMED THAT THE ANGLE OF THE SCREW WAS TOO INCLINED, BUT THE DRILL GUIDE WAS IN THE NORMAL RANGE. WHEN THE SCREW WAS TURNING TO LOCK, A PIECE OF METAL CAME OUT OF BETWEEN THE PLATE AND THE SCREW. A NEW LOCKING SCREW OF THE SAME SIZE WAS OPENED AND REINSERTED, AND IT WAS LOCKED. THE OPERATION IS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION REPORTED THAT: AFTER DRILLING AND BEFORE INSERTING THE SCREW, DRILLING INTO THE NEXT SCREW HOLE WAS MADE AND THEN INSERTING THE SCREW. THIS CAUSED THE PLATE TO SHIFT AND THE DRILL HOLE TO BE SHIFTED FROM THE INITIAL POSITION, WHICH SEEMED TO HAVE CAUSED LOCKING FAILURE. CUSTOMER / SALES REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9702276 ↗
• MalfunctionJan 21, 2020Material Fragmentation; Material Fragmentation

  WHEN INSERTING THE LOCKING SCREW (657312S) INTO THE PLATE ((B)(4)), A THIN METAL PIECE WAS GENERATED. IT HAS BEEN REMOVED AND NO LONGER REMAINS IN THE BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9614115 ↗
• MalfunctionNov 22, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SURGEON FOUND THE FOREIGN MATERIAL ON THIS SCREW AT OPENING OF PACKAGING. INSTEAD OF THIS, OTHER ONE WAS USED FOR A PROCEDURE. THE SURGEON STRONGLY REQUESTED TO IDENTIFY WHAT THE FOREIGN MATERIAL WAS, LIKE A HAIR, METAL WIRE, FIBER, AND SO ON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365359 ↗
• MalfunctionSep 16, 2019Difficult to Insert; Positioning Problem; Difficult to Insert

  AS REPORTED: "VARIAX CLAVICLE SURGERY WAS PERFORMED ON (B)(6) 2019. WHEN THE SURGEON TRIED TO LOCK THE LOCKING SCREW TO THE HOLE OF THE PLATE, IT DID NOT LOCK. HE EXCHANGED THE SCREW TO THE NEW ONE. THE SECOND SCREW WAS ABLE TO LOCKED TO THE PLATE." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9072948 ↗