NA 209.890Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982151230), received between Nov 21, 2022 and Sep 15, 2023 — classified as 2 injuries.

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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT HAD CAR/CAR COLLISION AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT 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 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. THIS REPORT INVOLVES ONE (1) 7.3MM CANNULATED SCREW 32MM THREAD/90MM. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4). (B)(4) CAPTURES ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT.

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

  MAUDE report 17755603 ↗
• InjuryNov 21, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS A REVISION OF A SACRAL NONUNION. THERE WAS A BROKEN SCREW, BUT IT WAS REMOVED. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 7.3MM CANNULATED SCREW 32MM THREAD/90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15837856 ↗