NA 214.850Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982154743), received between Oct 23, 2019 and Sep 20, 2021 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A REMOVAL PROCEDURE, THE PLATE WAS REMOVED DUE TO BONE HEALING FAILURE. THIS WAS IMPLANTED ON (B)(6) 2021. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 50MM. THIS REPORT IS 4 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12502218 ↗
• InjuryJun 29, 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 HARDWARE REMOVAL OF A RIGHT FEMUR FOR OSTEOMYELITIS INFECTION. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2019. ALL HARDWARE WAS REMOVED EASILY. THERE WAS (1) POSTOPERATIVELY BROKEN SCREW. NO FRAGMENTS WERE GENERATED FROM THE BROKEN IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 50MM. THIS IS REPORT 9 OF 15 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12088881 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT AN ANKLE ARTHROSCOPY, SYNOVECTOMY, OSTEOTOMY, OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FIBULA BECAUSE ONE OF THE SCREWS HAD FRACTURED WHICH HAD CAUSED PAIN AND FURTHER INJURY TO HER RIGHT LEG. ON (B)(6) 2019, THE PATIENT WENT TO THE ER BECAUSE OF ONGOING RIGHT FOOT NUMBNESS, LOSS OF SENSATION POST RIGHT FOOT SURGERY. THE PATIENT HAS BEEN SEEN BY THE ER PHYSICIAN AND WAS CLEARED STABLE TO DISCHARGE. THIS REPORT IS FOR 8 OF 8 FOR (B)(4). RELATED INCIDENT: (B)(4).

  Patient problems: Hypoesthesia

  MAUDE report 9225470 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT AN ANKLE ARTHROSCOPY, SYNOVECTOMY, OSTEOTOMY, OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FIBULA BECAUSE ONE OF THE SCREWS HAD FRACTURED WHICH HAD CAUSED PAIN AND FURTHER INJURY TO HER RIGHT LEG. ON (B)(6) 2019, THE PATIENT WENT TO THE ER BECAUSE OF ONGOING RIGHT FOOT NUMBNESS, LOSS OF SENSATION POST RIGHT FOOT SURGERY. THE PATIENT HAS BEEN SEEN BY THE ER PHYSICIAN AND WAS CLEARED STABLE TO DISCHARGE. THIS REPORT IS FOR 6 OF 8 FOR (B)(4). RELATED INCIDENT: (B)(4).

  Patient problems: Hypoesthesia

  MAUDE report 9225457 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT AN ANKLE ARTHROSCOPY, SYNOVECTOMY, OSTEOTOMY, OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FIBULA BECAUSE ONE OF THE SCREWS HAD FRACTURED WHICH HAD CAUSED PAIN AND FURTHER INJURY TO HER RIGHT LEG. ON (B)(6) 2019, THE PATIENT WENT TO THE ER BECAUSE OF ONGOING RIGHT FOOT NUMBNESS, LOSS OF SENSATION POST RIGHT FOOT SURGERY. THE PATIENT HAS BEEN SEEN BY THE ER PHYSICIAN AND WAS CLEARED STABLE TO DISCHARGE. THIS REPORT IS FOR 7 OF 8 FOR (B)(4). RELATED INCIDENT: (B)(4).

  Patient problems: Hypoesthesia

  MAUDE report 9225446 ↗