NA 202.838Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982144850), received between Aug 23, 2021 and Sep 14, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjurySep 14, 2023Break; Break

  IT WAS REPORTED THAT IN (B)(6) 2008, THE PATIENT HAD A CAR COLLISION AND WAS ADMITTED TO THE HOSPITAL. HE UNDERWENT SEVERAL SURGERIES FOR ORTHOPEDIC INJURIES INCLUDING AN OPEN REDUCTION INTERNAL FIXATION FOR A FRACTURE-DISLOCATION OF HIS FEMORAL HEAD AND NECK AND A SACROILIAC SCREW FIXATION AND ANTERIOR PUBIC PLATE FOR A MALGAIGNE FRACTURE. ON (B)(6) 2008, THE PATIENT UNDERWENT ORIF LEFT FEMORAL HEAD, ORIF LEFT FEMORAL NECK, ORIF LEFT ANTERIOR COLUMN ACETABULUM, ORIF PUBIC SYMPHYSIS (SYNTHES PELVIC PLATE ACROSS HIS PUBIS EXTENDING TO THE LEFT HIP) AND PERCUTANEOUS ILIOSACRAL SCREW FIXATION DUE TO LEFT ACETABULAR FRACTURE AND LEFT FEMORAL HEAD FRACTURE. ON (B)(6) 2010, THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY WITH DEPUY COMPONENTS DUE TO HIP PAIN, METALLOSIS, TRAUMATIC ARTHRITIS LEFT HIP WITH FEMORAL HEAD AVASCULAR NECROSIS AND NONUNION FEMORAL HEAD FRACTURE, MALGAIGNE FRACTURE AND INTRAARTICULAR HARDWARE BROKE WITH SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM CORTEX SCREW SELF-TAPPING 38MM. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: Foreign Body Reaction; Necrosis; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 17746280 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE FOR AN OPEN REDUCTION INTERNAL FIXATION OF PROXIMAL FEMUR THE SCREW HEADS WAS BROKEN. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME WAS AS PLANNED. THIS REPORT IS FOR (1) 2.7MM CORTEX SCREW SELF-TAPPING 45MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758914 ↗
• InjuryAug 23, 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 FOR A REMOVAL SURGERY. DURING THE SURGERY, ALL DEVICES WERE INTACT, NO ITEMS WERE BROKEN, AND WERE REMOVED SUCCESSFULLY AND WITHOUT DIFFICULTY. ORIGINALLY, THE PATIENT UNDERWENT FOR REMOVAL HARDWARE OF A LEFT TIBIAL SHAFT FRACTURE FOR INFECTION ON (B)(6) 2020. THE CURRENT REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT WAS FIN POSTOPERATIVELY. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) 2.7MM CORTEX SCREW SELF-TAPPING 38MM. THIS REPORT IS 12 OF 13 FOR (B)(4).

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

  MAUDE report 12356632 ↗