NA 204.845Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982146410), received between Apr 23, 2019 and Jun 27, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, TWO 3.5 CORTEX SCREWS BENT WHILE BEING USED WITH THE FARABEUF CLAMP. THE SURGEON APPLIED A LOT OF FORCE TO TRY TO CLOSE THE FRACTURE DOWN. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 3.5MM CORTEX SCREW SELF-TAPPING 45MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209637 ↗
• MalfunctionJun 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED, THAT DURING A PROCEDURE ON (B)(6) 2023. TWO 3.5 CORTEX SCREWS, BENT WHILE BEING USED WITH THE FARABEUF CLAMP. THE SURGEON APPLIED A LOT OF FORCE TO TRY TO CLOSE THE FRACTURE DOWN. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 3.5MM CORTEX SCREW SELF-TAPPING 45MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209600 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO A MEDIAL TIBIA WOUND, AND THE FRACTURE WAS HEALED. INITIALLY, THE PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) PLATING SYSTEM ON AN UNKNOWN DATE. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIXTEEN (16) DEVICES. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 45MM. THIS REPORT IS 3 OF 10 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 11132544 ↗
• InjurySep 27, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF THE ANKLE DUE TO A SYNDESMOTIC INJURY AND NEEDED SCREW FIXATION. WHILE THE SURGEON WAS PUTTING IN A SCREW, IT WAS PUT IN ON POWER AND WENT THROUGH THE FIBULA AND WHEN IT HIT THE TIBIA MUST HAVE MISSED THE TRACK FROM THE DRILL BIT AND AS IT HIT THE BONE THE SCREW BENT. SURGEON USED A BURR AND SCREW REMOVAL SET TO TAKE SCREW OUT AND A NEW SCREW WAS PUT IN. FRAGMENTS WERE REMOVED. THERE WAS A SURGICAL DELAY FOR UNKNOWN NUMBER OF MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY:2) UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY:1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9130020 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM BRAZIL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF THE IMPLANT DUE DISCOMFORT. ONE (1) CORTEX SCREW, THREE (3) UNKNOWN SCREWS, AND AN UNKNOWN PLATE WERE REMOVED. DUE TO THE POSITION OF THE CORTEX SCREW, IT WAS DIFFICULT TO REMOVE AND BROKE, HOWEVER ALL IMPLANTS WERE REMOVED SUCCESSFULLY. THE DOCTOR REPORTED NO HARM TO THE PATIENT AND NO OTHER POSSIBLE SURGERY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THIS REPORT IS FOR 3.5MM CORTEX SCREW SELF-TAPPING 45MM. THIS IS REPORT 1 OF 3 FOR (B)(4) AND CAPTURES THE CAUSE OF IMPLANT REMOVAL. THE INTRAOPERATIVE BREAKAGE IS CAPTURED UNDER (B)(4).

  Patient problems: Discomfort; No Code Available

  MAUDE report 8539436 ↗