VARIAX 657314Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613327086843), received between Dec 6, 2018 and Jul 8, 2025 — classified as 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.

• InjuryJul 8, 2025Biocompatibility; Biocompatibility

  AS REPORTED: "SURGEON ADVISED HE WAS REMOVING ONE OF OUR VARIAX FIBULA PLATES THAT HE HAD IMPLANTED 5 YEARS PRIOR & AT THE PLATE BONE INTERFACE AS PER ATTACHED PHOTO THERE WAS "GROSS METALLOSIS" AND "PRETTY BAD BONE EROSION" PLATE AND SCREWS HAVE BEEN SUCCESSFULLY REMOVED & WILL BE RETURNED ONCE DECONTAMINATED. SWABS HAVE BEEN SENT TO LOCAL PATHOLOGY."

  Patient problems: Erosion; Foreign Body Reaction

  MAUDE report 22441503 ↗
• InjuryMay 15, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A VARIAX CLAVICULA PLATE REMOVAL, WHILST REMOVING THE SCREWS AND PLATE THE SURGEON NOTICED SOME METAL PARTICLES IN THE WOUND. ADDITIONAL INFORMATION: THE REASON FOR THE REMOVAL OF THE PLATE WAS THE DISCOMFORT IT CAUSED. THERE WAS NO DEBRIS LEFT IN THE PATIENT.

  Patient problems: Discomfort

  MAUDE report 16930998 ↗
• MalfunctionNov 15, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS METAL DEBRIS AFTER REMOVING THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796155 ↗
• MalfunctionNov 14, 2019Difficult to Insert; Difficult to Insert; Fitting Problem

  IT WAS REPORTED A LOCKING SCREW WAS INSERTED INTO THE DISTAL LOCKING HOLE, BUT IT WAS UNABLE TO LOCK AND WAS SPINNING, AND A SMALL PIECE OF METAL WAS SEEN (WHETHER IT WAS THE PLATE SIDE OR THE SCREW SIDE). THE HOLE COULD NOT BE USED, AND THE OTHER SCREW WAS USED IN THE OTHER HOLE, BUT IT WAS STILL IDLE AND COULD NOT BE LOCKED. AFTER THAT, WHEN A NEW SCREW WAS USED, LOCKING WAS POSSIBLE WITHOUT ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9323877 ↗
• MalfunctionSep 9, 2019Appropriate Device Problem Term/Code Not Available

  AS REPORTED: "A PLASTIC FILM WAS FOUND TO COVERING SCREWS IN THE LOAN SETS CADDY WHICH HAD TO BE REMOVED PRIOR TO IMPLANTATION. SURGEON DECIDED TO CONTINUE ON WITH PROCEDURE NO REPLACEMENTS WERE ASKED FOR OR SORT." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974177 ↗
• MalfunctionSep 9, 2019Contamination /Decontamination Problem

  AS REPORTED: "A PLASTIC FILM WAS FOUND TO COVERING SCREWS IN THE LOAN SETS CADDY WHICH HAD TO BE REMOVED PRIOR TO IMPLANTATION. SURGEON DECIDED TO CONTINUE ON WITH PROCEDURE NO REPLACEMENTS WERE ASKED FOR OR SORT." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974175 ↗
• MalfunctionSep 9, 2019Malposition of Device

  AS REPORTED: "A PLASTIC FILM WAS FOUND TO COVERING SCREWS IN THE LOAN SETS CADDY WHICH HAD TO BE REMOVED PRIOR TO IMPLANTATION. SURGEON DECIDED TO CONTINUE ON WITH PROCEDURE NO REPLACEMENTS WERE ASKED FOR OR SORT." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974172 ↗
• MalfunctionSep 9, 2019Malposition of Device

  AS REPORTED: "A PLASTIC FILM WAS FOUND TO COVERING SCREWS IN THE LOAN SETS CADDY WHICH HAD TO BE REMOVED PRIOR TO IMPLANTATION. SURGEON DECIDED TO CONTINUE ON WITH PROCEDURE NO REPLACEMENTS WERE ASKED FOR OR SORT." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974171 ↗
• MalfunctionSep 9, 2019Malposition of Device

  AS REPORTED: "A PLASTIC FILM WAS FOUND TO COVERING SCREWS IN THE LOAN SETS CADDY WHICH HAD TO BE REMOVED PRIOR TO IMPLANTATION. SURGEON DECIDED TO CONTINUE ON WITH PROCEDURE NO REPLACEMENTS WERE ASKED FOR OR SORT." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974170 ↗
• MalfunctionSep 9, 2019Appropriate Device Problem Term/Code Not Available

  AS REPORTED: "A PLASTIC FILM WAS FOUND TO COVERING SCREWS IN THE LOAN SETS CADDY WHICH HAD TO BE REMOVED PRIOR TO IMPLANTATION. SURGEON DECIDED TO CONTINUE ON WITH PROCEDURE NO REPLACEMENTS WERE ASKED FOR OR SORT." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974169 ↗
• MalfunctionSep 9, 2019Appropriate Device Problem Term/Code Not Available

  AS REPORTED: "A PLASTIC FILM WAS FOUND TO COVERING SCREWS IN THE LOAN SETS CADDY WHICH HAD TO BE REMOVED PRIOR TO IMPLANTATION. SURGEON DECIDED TO CONTINUE ON WITH PROCEDURE NO REPLACEMENTS WERE ASKED FOR OR SORT." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974168 ↗
• MalfunctionSep 9, 2019Appropriate Device Problem Term/Code Not Available

  AS REPORTED: "A PLASTIC FILM WAS FOUND TO COVERING SCREWS IN THE LOAN SETS CADDY WHICH HAD TO BE REMOVED PRIOR TO IMPLANTATION. SURGEON DECIDED TO CONTINUE ON WITH PROCEDURE NO REPLACEMENTS WERE ASKED FOR OR SORT." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974167 ↗
• InjuryJul 29, 2019Detachment of Device or Device Component

  CLAVICLE REVISION CASE; REVISION WAS DUE TO PREVIOUS PLATE AND SCREWS PULLING OUT FROM BONE. SURGEON BELIEVES THIS WAS DUE TO THE PATIENT 'LIFTING WEIGHTS' IN THE GYM EARLIER THAN ADVISED AFTER SURGERY. REVISION CASE WENT ACCORDING TO PLAN WITH NO ISSUES ENCOUNTERED. PATIENT WAS COMPLIANT AND IN A SLING FOR 2 MONTHS. PATIENT IS ALSO A HEAVY SMOKER AND WENT BACK TO WORK AS A CONCRETER AFTER 2 MONTHS POST CASE.

  Patient problems: No Code Available

  MAUDE report 8839482 ↗
• InjuryJul 29, 2019Detachment of Device or Device Component

  CLAVICLE REVISION CASE; REVISION WAS DUE TO PREVIOUS PLATE AND SCREWS PULLING OUT FROM BONE. SURGEON BELIEVES THIS WAS DUE TO THE PATIENT 'LIFTING WEIGHTS' IN THE GYM EARLIER THAN ADVISED AFTER SURGERY. REVISION CASE WENT ACCORDING TO PLAN WITH NO ISSUES ENCOUNTERED. PATIENT WAS COMPLIANT AND IN A SLING FOR 2 MONTHS. PATIENT IS ALSO A HEAVY SMOKER AND WENT BACK TO WORK AS A CONCRETER AFTER 2 MONTHS POST CASE.

  Patient problems: No Code Available

  MAUDE report 8839438 ↗
• InjuryJul 29, 2019Detachment of Device or Device Component

  CLAVICLE REVISION CASE; REVISION WAS DUE TO PREVIOUS PLATE AND SCREWS PULLING OUT FROM BONE. SURGEON BELIEVES THIS WAS DUE TO THE PATIENT 'LIFTING WEIGHTS' IN THE GYM EARLIER THAN ADVISED AFTER SURGERY. REVISION CASE WENT ACCORDING TO PLAN WITH NO ISSUES ENCOUNTERED. PATIENT WAS COMPLIANT AND IN A SLING FOR 2 MONTHS. PATIENT IS ALSO A HEAVY SMOKER AND WENT BACK TO WORK AS A CONCRETER AFTER 2 MONTHS POST CASE.

  Patient problems: No Code Available

  MAUDE report 8839437 ↗
• InjuryJul 29, 2019Detachment of Device or Device Component

  CLAVICLE REVISION CASE; REVISION WAS DUE TO PREVIOUS PLATE AND SCREWS PULLING OUT FROM BONE. SURGEON BELIEVES THIS WAS DUE TO THE PATIENT 'LIFTING WEIGHTS' IN THE GYM EARLIER THAN ADVISED AFTER SURGERY. REVISION CASE WENT ACCORDING TO PLAN WITH NO ISSUES ENCOUNTERED. PATIENT WAS COMPLIANT AND IN A SLING FOR 2 MONTHS. PATIENT IS ALSO A HEAVY SMOKER AND WENT BACK TO WORK AS A CONCRETER AFTER 2 MONTHS POST CASE.

  Patient problems: No Code Available

  MAUDE report 8839394 ↗
• InjuryDec 19, 2018Appropriate Device Problem Term/Code Not Available

  THIS PI IS FOR THE REVISION ON (B)(6) 2018. AS REPORTED: "PATIENT'S MOTHER...CONTACTED OUR OFFICE STATING HER DAUGHTER'S ALLERGIST ADVISED HER TO CALL ABOUT THE IMPLANTS USED ON HER DAUGHTER...SPOKE WITH CROSSLINK CUSTOMER SERVICE REP...WHO HAS PROVIDED PATIENT'S MOTHER WITH THE STRYKER ASSIST NUMBER. THERE WAS A REVISION CASE DONE ON (B)(6) 2018 FOR THE FOLLOWING ITEMS: 40-35614 QTY 1 AND 703667 QTY 1". SPOKE TO REPORTER. NO REACTIONS, ALLERGIC OR OTHERWISE, WERE REPORTED. THE TWO CATALOG NUMBERS PROVIDED IN THE PRECEDING EXPLANATION WERE IMPLANTED ON (B)(6) 2018 AND DO NOT APPEAR ON A SURGERY SHEET PROVIDED WITH A DATE OF SURGERY (B)(6) 2018. IT IS UNCLEAR IF THE PRIMARY IMPLANT, THE REVISION, OR BOTH TRIGGERED THE CALL. THE JUNE 5 DEVICES LISTED ARE A SCREW AND A SCREWDRIVER BLADE. PER UPDATE RECEIVED FROM REP: THE REVISION WAS TO REMOVE A SCREW HE BELIEVED WAS TOO LONG AND POSSIBLY CAUSING THE IRRITATION THE PATIENT WAS EXPERIENCING. A SHORTER SCREW WAS PUT IN THE PATIENT. THE SCREW THAT WAS REMOVED WAS REMOVED IN JUNE SO IT CAN¿T BE PRESENTED. THERE WAS NO PROBLEM WITH THE SCREW. THE DOCTOR JUST BELIEVED IT WAS LONG. THE PLATE AND ALL SCREWS ARE TITANIUM AND SHOULD NOT BE GIVI

  Patient problems: Irritation

  MAUDE report 8182798 ↗
• MalfunctionDec 6, 2018Connection Problem

  AS REPORTED: "I WAS THE REP FOR [SURGEON] WHILE USING OUR FIBULA PLATE. THERE WERE TWO LOCKING SCREWS ON THE DISTAL END OF THE FIBULA PLATE THAT WOULDN'T LOCK DOWN IN THE PLATE CORRECTLY...THE TECHNIQUES THAT WERE USED TO IMPLANT THE SCREWS WERE CORRECT. WE USED THE CORRECT DRILL BIT WITH ITS CORRESPONDING DRILL GUIDE AS WELL. [SURGEON] EXPLANTED THESE TWO SCREWS AND REPLACED THEM WITH TWO OTHER LOCKING SCREWS. THE TWO REPLACEMENT SCREWS WENT IN CORRECTLY UNDER THE SAME TECHNIQUE...[SURGEON] WOULD LIKE TO HAVE THIS SITUATION REPORTED SO THAT WE CAN INVESTIGATE ANY REASONS OF WHY THE LOCKING SCREWS WEREN'T FIXATING PROPERLY".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8139821 ↗