NA 414.846Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982213730), received between Oct 25, 2019 and Sep 30, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FRACTURE OF FEMORAL TROCHANTER WITH 3 SCREWS. ON SEPTEMBER 5, WHEN THE PATIENT VISITED THE HOSPITAL DUE TO PAIN, IT WAS CONFIRMED THAT 3 SCREWS WERE BROKEN. THE REOPERATION IS NOT SCHEDULED BECAUSE THE PATIENT FEELS A LITTLE PAIN. IF THE REOPERATION IS PERFORMED, THE ARTIFICIAL BONE HEAD WILL BE USED. EXCESSIVE TELESCOPING OCCURRED BECAUSE THE BONE FRAGMENT WAS INTRAMEDULLARY. WHEN THE BLADE CONTACTED THE BARREL PORTION OF THE PLATE, TELESCOPING WAS SUPPRESSED, AND THE IMPLANT COULD NOT TOLERATE THE LOAD OF THE VARUS OF THE BONE FRAGMENT, WHICH MAY HAVE CAUSED THE SCREW TO BREAK. DISTAL PLATE PORTION BOUNCES OUTWARD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.5MM TI CORTEX SCREW SELF-TAPPING 46MM. THIS IS REPORT 3 OF 3 FOR (B)(4)..

  Patient problems: Pain

  MAUDE report 15519788 ↗
• 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 7 OF 7 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9241256 ↗