VARIAX 657316SRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07613327086881), received between Sep 27, 2019 and Jul 1, 2025 — classified as 3 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 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 22378051 ↗
• MalfunctionFeb 28, 2025Positioning Failure; Positioning Failure

  AS REPORTED: "THE LOCKING SCREW DID NOT LOCK. ANOTHER SCREW (SAME SIZE, ANOTHER LOT#) COULD BE USED INSTEAD OF THE REPORTED SCREW AND IT COULD BE LOCKED, SO THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21497146 ↗
• InjurySep 16, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A VARIAX CLAVICLE PLATE WAS INSERTED ON (B)(6) 2023. THE PATIENT WAS FOLLOWED UP WITH AFTER THE PROCEDURE AND IT WAS NOTED THAT THE PROGRESS OF BONE FUSION WAS POOR. THE SURGEON AT THE TIME SUGGESTED REPLACING THE PLATE WITH A BONE GRAFT, HOWEVER THIS WAS NOT FOLLOWED THROUGH. ON (B)(6) 2023 THE PATIENT FELT PAIN AND VISITED A DIFFERENT HOSPITAL WHERE IT WAS DISCOVERED THAT THE PLATE WAS BROKEN. ON (B)(6) 2023 THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE BROKEN PLATE. DURING THE EVALUATION OF THE DEVICE, IT WAS FOUND THAT ONE OF THE TWO LOCKING SCREWS WITH THE CATALOG # 657316 HAD A BROKEN THREAD FLANK.

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

  MAUDE report 20225082 ↗
• MalfunctionJul 17, 2024Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767533 ↗
• MalfunctionJul 11, 2024Positioning Failure; Positioning Failure

  THE SALES REPRESENTATIVE REPORTED A CASE THAT HAD A LOCKING SCREW FAIL TO LOCK. HOLE WAS INTENDED TO BE FILLED WITH A 16MM LOCKING SCREW. THE SCREW HAD ALL THE HALLMARKS OF BEING A LOCKING SCREW (HEAD OF SCREW WAS GREY) HOWEVER AS THE SCREW BECAME SEATED IN THE PLATE IT FAILED TO LOCK AND JUST WAS SPINNING IN THE PLATE. MULTIPLE ATTEMPTS WERE MADE AND THEN THIS WAS SWAPPED TO A 14MM WHICH LOCKED WITH NO ISSUES. DELAY TO PROCEDURE: 5-10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19722554 ↗
• MalfunctionJul 11, 2024Positioning Failure; Positioning Failure

  THE SALES REPRESENTATIVE REPORTED A CASE THAT HAD A LOCKING SCREW FAIL TO LOCK.HOLE WAS INTENDED TO BE FILLED WITH A 16MM LOCKING SCREW. THE SCREW HAD ALL THE HALLMARKS OF BEING A LOCKING SCREW (HEAD OF SCREW WAS GREY) HOWEVER AS THE SCREW BECAME SEATED IN THE PLATE IT FAILED TO LOCK AND JUST WAS SPINNING IN THE PLATE. MULTIPLE ATTEMPTS WERE MADE AND THEN THIS WAS SWAPPED TO A 14MM WHICH LOCKED WITH NO ISSUES.DELAY TO PROCEDURE: 5-10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19722553 ↗
• MalfunctionJun 18, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "LOCKING FAILURE OF LOCKING SCREW TO PLATE. NEW SCREW WAS OPENED AND REINSERTED, AND IT WAS LOCKED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559664 ↗
• 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 19068008 ↗
• MalfunctionApr 12, 2023Positioning Failure; Naturally Worn; Positioning Failure; Naturally Worn

  AS REPORTED: "INSERTED SCREW INTO VARIAX ELBOW PLATE BUT DID NOT LOCK PROPERLY. AFTER REMOVAL, THE SCREW WAS CHECKED. VISUALLY, THE THREADS NEAR THE SCREW HEAD SEEMED TO BE THINNING. THE SCREW WAS NOT REPLACED IN THE SCREW HOLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728290 ↗
• MalfunctionFeb 10, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "THE 3.5 MM LOCKING SCREW DID NOT LOCK WITH THE VARIAX FIBRAPLATE. REPLACED NEW SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353085 ↗
• MalfunctionSep 2, 2022Positioning Failure; Positioning Failure

  AS REPORTED: THE LOCKING SCREW COULD NOT LOCK ONTO THE PLATE WHEN USING THE FIBULA PLATE. WHEN THE SCREW WAS REPLACED, THE LOCKING SCREW WAS ABLE TO LOCK ONTO THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15347030 ↗
• MalfunctionAug 9, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "INTRAOPERATIVELY, DRILLING AFTER PLATE PLACEMENT. EVEN THOUGH IT IS FASTENED WITH 2 FINGERS AND NO EXCESSIVE FORCE IS APPLIED, A LOCKING SCREW DOES NOT LOCK TO THE PLATE. A NEW SCREW WAS OPENED AND INSERTED, BUT IT WAS SPINNING. THE SCREW WAS REPLACED WITH A NON-LOCKING SCREW, BUT IT WAS NOT FIX TO THE BONE. THE NON-LOCKING SCREW WAS LEFT AS IT IS. THE DOCTOR'S OPINION WAS THAT THERE WAS NO SENSATION OF THE DRILL SLEEVE SWINGING MORE THAN THE VARIABLE 15 DEGREES, AND EVEN THOUGH THE DRILLING WAS WITHIN THE ACCEPTABLE RANGE, IT DID NOT LOCK. THE UNFIXATION OF THE NON-LOCKING SCREW WAS PROBABLY BECAUSE THE CORTICAL BONE WAS BROKEN DURING INSERTION OF THE LOCKING SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191766 ↗
• MalfunctionApr 5, 2022Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14012516 ↗
• InjuryAug 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE MOST MEDIAL SCREW LOOSENED FROM 3 WEEKS AFTER THE OPERATION, AND FINALLY THE LOCK WAS RELEASED AND ALL THE IMPLANTS CAME OFF. ON (B)(6) 2021, REVISION SURGERY WAS PERFORMED AND IT WAS REPLACED WITH A LONG PLATE.

  Patient problems: Failure of Implant

  MAUDE report 12316066 ↗
• MalfunctionMay 14, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THE LOCKING SCREW COULD NOT BE LOCKED WELL DURING A VARIAX FOOT OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828786 ↗
• 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 10597513 ↗
• MalfunctionAug 28, 2020Material Fragmentation; Material Fragmentation

  AS REPORTED: "WHEN I INSERTED THE SCREW AFTER DRILLING AS USUAL, A THIN THREAD-SHAPED METAL PIECE CAME OUT FROM THE SCREW TWICE. I PULLED IT OUT, AND WHEN I LOOKED AT THE SCREW, THE THREAD WAS PEELED OFF. I REPLACED IT WITH ANOTHER SCREW AND COULD INSERT IT SAFELY. THE ANGLE OF THE DRILL WAS NOT BAD. AFTER THAT ANOTHER SCREW ENTERED AS USUAL."

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

  MAUDE report 10467339 ↗
• MalfunctionAug 18, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "DURING THE INITIAL OPERATION ON (B)(6) 2020, THE LOCKING SCREW DID NOT LOCK TO THE PLATE. SO, THE SCREW WAS REMOVED. WHEN IT WAS PULLED OUT, THREAD-SHAPED METAL PIECES [...] WAS FOUND. AFTER SCREW WAS EXCHANGED WITH NEW ONE, IT WAS ABLE TO LOCK WITHOUT PROBLEM."

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

  MAUDE report 10423136 ↗
• MalfunctionAug 4, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN USING THE VARIAX LOCKING SCREW, THE PLATE AND SCREW DID NOT LOCK." ADDITIONALLY REPORTED: "ONLY ONE HOLE IN THE PLATE COULD NOT BE LOCKED. THE PROCEDURE ENDED WITHOUT INSERTING A SCREW INTO THE HOLE."

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

  MAUDE report 10365322 ↗
• MalfunctionAug 4, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN USING THE VARIAX LOCKING SCREW, THE PLATE AND SCREW DID NOT LOCK." ADDITIONALLY REPORTED: "ONLY ONE HOLE IN THE PLATE COULD NOT BE LOCKED. THE PROCEDURE ENDED WITHOUT INSERTING A SCREW INTO THE HOLE."

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

  MAUDE report 10365320 ↗
• MalfunctionJul 10, 2020Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  IT WAS REPORTED: LOCKING PLATE AND LOCKING SCREW DID NOT LOCK. THE SCREW WAS REPLACED WITH OTHER ONE, AND ABLE TO LOCK WITH THE PLATE. THE LOT # OF THE SCREW WHICH DID NOT LOCK IS UNKNOWN BUT THE REPORTER REQUESTED TO INVESTIGATE IF LOCKING WAS UNSUCCESSFUL WITH THE SAME LOT (3 OF THEM).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10261165 ↗
• MalfunctionJun 22, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "DURING SCREW OPERATION OF VARIAX FIBRA, LOCKING FAILURE OF THE SCREW OCCURRED. I TRIED TO USE THE SAME SCREW IN ANOTHER SCREW HOLE, BUT IT DID NOT LOCK AS WELL. WHEN THE NEW SCREW WAS OPENED AND USED, IT LOCKED NORMALLY. THE DOCTOR SAID THE THREAD ON THE SCREW MIGHT HAVE BEEN SCRAPED WHEN THE SCREW WAS INSERTED".

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

  MAUDE report 10182035 ↗
• MalfunctionJun 9, 2020Residue After Decontamination; Residue After Decontamination

  THE SURGEON FOUND THE SCREW ENTWINED WITH METAL DEBRIS AT OPENING THE STERILE PACKAGING. THE METAL DEBRIS WAS REMOVED AND THE SCREW WAS USED FOR PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10135855 ↗
• MalfunctionMay 6, 2020Positioning Failure; Positioning Failure

  AS REPORTED, WHEN THE LOCKING SCREW 16MM WAS INSERTED INTO THE DISTAL PART OF THE VARIAX DISTAL FIBRA PLATE, IDLING OCCURRED BEFORE THE FINAL FASTENING. ONCE THE SCREW WAS REMOVED, METAL SUCH AS WIRE WAS WOUND AROUND THE THREAD OF THE SCREW. WHEN THE SAME SCREW WAS NEWLY INSERTED, THE LOCKING WAS LOOSE. THE OPERATION WAS TERMINATED BECAUSE THE OTHER SCREWS WERE SECURELY LOCKED. DOCTOR'S OPINION: THE METAL WRAPPED AROUND THE SCREW IS A SCRAPED PLATE. THIS IS WHY THE PLATE AND SCREW COULD NOT BE LOCKED, AND THE NEW SCREW WAS LOOSENED. IT IS DANGEROUS BECAUSE THERE IS A POSSIBILITY OF LEAVING METAL SCRAPED INSIDE THE BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10029081 ↗
• MalfunctionFeb 13, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED, ONE SCREW COULD NOT BE LOCKED IN THE PROXIMAL SCREW HOLE OF THE ELBOW PLATE. THE DOCTOR JUDGED THAT THERE WAS NO PROBLEM EVEN IF THE SCREW WAS NOT FIXED THERE, AND THE PROCEDURE WAS TERMINATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9705806 ↗