NA 245.033Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982169471), received between Oct 3, 2023 and Oct 3, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM INDIA REPORTS AN EVENT AS FOLLOWS: ON (B)(6), 2022 THE PATIENT MET WITH A ROAD TRAFFIC ACCIDENT THROUGH BIKE AND SUSTAINED INJURIES, HEAD AND PELVIC FRACTURE. THE INJURIES ARE LIKE HEAD INJURY, DIFFUSE TRAUMATIC SUBARACHNOID HEMORRHAGE, LEFT ORBITAL WALL FRACTURE AND PATELLA/LEFT HIP FRACTURE. ON (B)(6), 2022 THE PATIENT UNDERWENT (1ST COMPONENT) OPEN REDUCTION & INTERNAL FIXATION WITH TENSION BOND WIRING FOR LEFT PATELLA. (2ND COMPONENT) ORIF RECON PLATE FOR ANTERIOR COLUMN LEFT ACETABULUM. (3RD COMPONENT) ORIF WITH RECON PLATE POSTERIOR COLUMN LEFT ACETABULUM. ON (B)(6), 2022 THE DISTAL FEMUR PIN APPLIED DUE TO THE SURGEON DID NOT PROPERLY USED THE C-ARM AND IGNORE THE COMPONENT LEFT PATELLA WHICH LED TO THE IMPLANT GOT FAILED DUE TO DISCREPANCY REDUCTION AND USING PINS FOR TEMPORARY SOLUTION/TREATMENT. ON (B)(6), 2022 LEFT FRONTAL BURR HOLE EVACUATION OF SUBDURAL COLLECTION & PLACEMENT OF SUBDURAL RESERVOIR. ON (B)(6), 2022 THE PATIENT UNDERWENT (2ND COMPONENT OF 1ST SURGERY) REVISION ACETABULUM WITH AO POSTERIOR PLATE. ANTERIOR QUADRILATERAL PLATE AND AO BUTTRESS PLATE (RE-DO OF 3RD ITEM OF THE 1ST SURGERY DUE TO THE FRACTURE REDUCTION GOT FAILED WITH A STIFF

  Patient problems: Deformity/ Disfigurement; Muscular Rigidity

  MAUDE report 17863665 ↗