TOMOFIX 440.831Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982220677), received between Jul 10, 2018 and Oct 25, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REVISION PROCEDURE OF A TOMOFIX OPENING WEDGE NAIL TIBIAL OSTEOTOMY DUE TO NON-UNION. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH A TOMOFIX OSTEOTOMY SYSTEM ON (B)(6) 2019. THE TOMOFIX PLATE, FIVE (5) LOCKING HEAD SCREWS AND ONE (1) CORTEX SCREW WERE EXPLANTED AND A NEW PLATE AND SCREWS WERE PUT IN WITH THE SAME PLATE AND SCREWS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DURING REVISION. PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS 1 OF 7 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9241081 ↗
• InjuryJul 10, 2018Mechanical Problem; Mechanical Problem

  (B)(6) REPORTS THAT DURING REMOVAL OF TOMOFIX LATERAL DISTAL FEMUR PLATE ON AN UNKNOWN DATE, THE SURGEON DESCRIBED THE SCREW AND PLATE JUNCTION STATUS AS ¿COLD WELDING¿. THE SURGEON HAD TROUBLE REMOVING THE TITANIUM TOMOFIX PLATE BECAUSE THE UNKNOWN SCREWS STRONGLY ADHERED TO THE PLATE. THE SURGEON ALWAYS FINISHED THE LAST SCREW INSERTION THREADS USING A TORQUE LIMITING SCREWDRIVER AS DESCRIBED AND PROPOSED IN THE TECHNIQUE GUIDE. DURING THE REMOVAL, THE SURGEON HAD TO USE A BROKEN SCREW REMOVAL SET AND DIAMOND BURR TO SHEAR OFF THE SCREW HEAD AT THE PLATE JUNCTION TO ENABLE REMOVAL OF THE PLATE AND SCREW CONSTRUCT. THE TITANIUM SCREWS WERE SO JAMMED IN THE PLATE THAT WHEN USING THE BROKEN SCREW REMOVAL QUICK COUPLING T-HANDLE, THE SHAFT OF THE T-HANDLE BECAME TWISTED AND NOT REUSABLE. THE SURGEON HAD TO USE A NEW ONE. THE SURGEON ADDED THAT THE PLATE ALWAYS ACHIEVED CLINICAL RESULT GOAL BUT THE CONSTRUCT IS A NIGHTMARE TO REMOVE AFTER BONE HEALING. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY RELATED TO THE EVENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR A TITANIUM TOMOFIX MEDIAL HIGH TIBIA PLATE-4 HOLES/SMALL. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7675201 ↗
• InjuryJul 10, 2018Mechanical Problem; Mechanical Problem

  (B)(6) REPORTS THAT DURING REMOVAL OF TOMOFIX LATERAL DISTAL FEMUR PLATE ON AN UNKNOWN DATE, THE SURGEON DESCRIBED THE SCREW AND PLATE JUNCTION STATUS AS ¿COLD WELDING¿. THE SURGEON HAD TROUBLE REMOVING THE TITANIUM TOMOFIX PLATE BECAUSE THE UNKNOWN SCREWS STRONGLY ADHERED TO THE PLATE. THE SURGEON ALWAYS FINISHED THE LAST SCREW INSERTION THREADS USING A TORQUE LIMITING SCREWDRIVER AS DESCRIBED AND PROPOSED IN THE TECHNIQUE GUIDE. DURING THE REMOVAL, THE SURGEON HAD TO USE A BROKEN SCREW REMOVAL SET AND DIAMOND BURR TO SHEAR OFF THE SCREW HEAD AT THE PLATE JUNCTION TO ENABLE REMOVAL OF THE PLATE AND SCREW CONSTRUCT. THE TITANIUM SCREWS WERE SO JAMMED IN THE PLATE THAT WHEN USING THE BROKEN SCREW REMOVAL QUICK COUPLING T-HANDLE, THE SHAFT OF THE T-HANDLE BECAME TWISTED AND NOT REUSABLE. THE SURGEON HAD TO USE A NEW ONE. THE SURGEON ADDED THAT THE PLATE ALWAYS ACHIEVED CLINICAL RESULT GOAL BUT THE CONSTRUCT IS A NIGHTMARE TO REMOVE AFTER BONE HEALING. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY RELATED TO THE EVENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR A TITANIUM TOMOFIX MEDIAL HIGH TIBIA PLATE-4 HOLES/SMALL. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7675199 ↗