NA 204.846Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982146427), received between Feb 25, 2018 and May 24, 2021 — classified as 3 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 18, 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.

• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HARDWARE REMOVAL FOR THE FIBULA PLATE AND SCREWS AND 2 ASSOCIATED LAG SCREWS. THE SURGEON PERFORMED I&D AND NOTED THAT THE BONE IS MOSTLY HEALED AND APPEARED TO HAVE NO SIGN OF INFECTION. INITIALLY THE PATIENT HAD SURGERY TO REPAIR A FIBULA FRACTURE 4 OR 5 MONTHS AGO. AFTER 3 MONTHS POST OP THERE WAS A SIGN OF INFECTION AND TRIED TO TREAT WITH ANTIBIOTICS WITHOUT SUCCESS. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 46MM. THIS REPORT IS 12 OF 14 (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11873627 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HARDWARE REMOVAL FOR THE FIBULA PLATE AND SCREWS AND 2 ASSOCIATED LAG SCREWS. THE SURGEON PERFORMED I&D AND NOTED THAT THE BONE IS MOSTLY HEALED AND APPEARED TO HAVE NO SIGN OF INFECTION. INITIALLY THE PATIENT HAD SURGERY TO REPAIR A FIBULA FRACTURE 4 OR 5 MONTHS AGO. AFTER 3 MONTHS POST OP THERE WAS A SIGN OF INFECTION AND TRIED TO TREAT WITH ANTIBIOTICS WITHOUT SUCCESS. THIS COMPLAINT INVOLVES 11 DEVICES. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 46MM. THIS REPORT IS 5 OF 14 (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11873589 ↗
• InjuryFeb 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE LEGAL DEPARTMENT REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT ON (B)(6) 2013 (APPROXIMATE DATE), PATIENT ASSISTED A FRIEND BY LOADING A MOTORCYCLE ON TO A TRAILER WHEN THE MOTORCYCLE FELL ON TO HIS LOWER RIGHT LEG. PATIENT SUSTAINED A DISTAL TIBIA AND FIBULA FRACTURE ABOVE THE RIGHT ANKLE. PATIENT UNDERWENT SURGERY ON (B)(6) 2013 (APPROXIMATE DATE) TO IMMOBILIZE THE LOWER RIGHT LEG/ANKLE FOR THE HEALING PROCESS AND WAS IMPLANTED WITH SYNTHES LOCKING SMALL FRAGMENT SET WHICH CONSISTED OF PLATES AND SCREWS. IN (B)(6) 2015 PATIENT NOTICED PAIN AND SWELLING AND A CURVATURE THAT BEGAN TO DEVELOP IN HIS LOWER RIGHT LEG/ANKLE AND WENT TO THE EMERGENCY ROOM IN (B)(6) OF 2015 AT ONE HOSPITAL AND THEN TO ANOTHER HOSPITAL DUE TO THE PAIN AND THE DEFORMITY DEVELOPING IN HIS LOWER RIGHT LEG/ANKLE. X-RAYS TAKEN ON (B)(6) 2015 (APPROXIMATE DATE) AND AGAIN ON (B)(6) 2015 (APPROXIMATE DATE) REVEALING A CURVATURE/DEFORMITY . IT WAS NOTED THAT THE PLATE WAS BROKEN ALONG WITH MANY OF THE SCREWS AND THERE WAS A NONUNION OF THE TIBIA AND FIBULA FRACTURES. AFTER THE EMERGENCY ROOM VISIT, PATIENT WENT TO A MEDICAL CENTER FOR FURTHER EVALUATION. PATIENT WAS INFORMED ABOUT UNDERGOING REVISION SURG

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7295383 ↗