NA 413.334Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982212009), received between Jun 25, 2018 and Oct 25, 2019 — classified as 2 injuries.

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 2 most recent of 2 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 3 OF 7 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9241106 ↗
• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT OPEN WEDGE HIGH TIBIAL OSTEOTOMY WAS APPLIED TO GONARTHROSIS IN THE RIGHT KNEE ON (B)(6) 2017. THE SURGERY WAS COMPLETED WITHOUT A DELAY. POSTOPERATIVELY, THE PATIENT¿S BONE UNION HAS BEEN SLOWER THAN EXPECTED. THROUGH X-RAYS TAKEN IN (B)(6) 2018, A GAP WAS NOTICED AROUND THE ARTIFICIAL JOINT. THIS COMPLAINT IS RELATED TO (B)(4), WHICH ACCOUNTS FOR THE LEFT KNEE OF THE SAME PATIENT. THIS REPORT IS FOR A 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 34MM. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 7633529 ↗