NA 204.865Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982146533), received between Aug 19, 2021 and Nov 20, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 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.

• MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE AUDITING A SCREW CADDY, SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610461 ↗
• MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE AUDITING A SCREW CADDY, SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610454 ↗
• MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE AUDITING A SCREW CADDY, SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610451 ↗
• MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE AUDITING A SCREW CADDY, SCREWS WERE FOUND TO BE DAMAGED. THE SCREW THREADS SEEMED FILED DOWN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610449 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING AN OPEN REDUCTION AND INTERNAL FIXATION RIGHT ACETABULAR FRACTURE, THE SURGEON IMPLANTED SYNTHES LOW PROFILE PELVIC PLATES AND 3.5 MM CORTEX SCREWS. THE PATIENT NOW PRESENTS WITH LOW GRADE INFECTION OF THE RIGHT HIP AND ACETABULUM. THE SURGEON HAS ELECTED TO REMOVE THE ACETABULAR HARDWARE AND THE TOTAL HIP TO HELP CLEAR UP THE INFECTION. ALL SCREWS AND 1 PLATE WERE REMOVED. ONE OF THE SCREWS WAS STRIPPED AND REQUIRED TOOLS FROM THE SCREW REMOVAL SET TO REMOVE. ALL HARDWARE WAS REMOVED AND NONE OF THE HARDWARE WAS BROKEN. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 65MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 12344563 ↗