NA 626675SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327088649), received between Aug 20, 2020 and Jul 9, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

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

• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE INITIAL SURGERY WAS PERFORMED ON (B)(6), BUT AS A NON-UNION WAS DETECTED, REVISION SURGERY WAS CARRIED OUT ON (B)(6). A STRAIGHT PLATE WAS REMOVED, AND THE SITE WAS FILLED WITH ILIAC BONE HARVESTED FROM THE PATIENT. PHOTOS WERE PROVIDED FROM THE FACILITY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 25764809 ↗
• InjuryAug 20, 2020Material Twisted/Bent; Material Twisted/Bent

  THE FOLLOWING WAS REPORTED: "(B)(6) YOM HAD LEFT RADIAL AND ULNAR SHAFT FRACTURES AFTER FALLING FROM A BICYCLE AND HAD OPEN REDUCTION AND INTERNAL FIXATION (B)(6) 2020. IMMEDIATE POST-OP X-RAY SHOWED A STRAIGHT PLATE. AT 2 WEEK FOLLOW-UP THERE WAS ANGULATION AT THE RADIAL FRACTURE SITE. PATIENT TAKEN TO SURGERY FOR REVISION OF FIXATION LEFT RADIUS AND ULNA AND A SHORT ARM CASE APPLIED. WHEN REMOVED DURING SURGERY, THE PLATE WAS FOUND TO BE BENT THROUGH THE CENTRAL PORTION, NO LOOSENING OF SCREWS. ALL SCREWS HAD GREAT PURCHASE." "DISCHARGE INSTRUCTIONS AFTER FIRST SURGERY: KEEP WELL-PADDED SHORT ARM CAST CLEAN AND DRY AT ALL TIMES. ELEVATE FOR A FEW DAYS FOR SWELLING. WEAR SLING WHEN OUT OF BED. GENERAL PEDIATRIC DISCHARGE EDUCATION INCLUDES NO BICYCLE, SKATEBOARD, SCOOTER, ETC. FOR NEXT 24 HOURS." "AT TWO WEEK CHECK-UP, PATIENT DOING WELL, NO PAIN IN THE CAST. PATIENT DENIES ANY FALLS, CAST IS SOMEWHAT LOOSE. WHEN CAST REMOVED THERE WAS CLINICAL DEFORMITY OF THE APEX DORSAL. NO SIGNS OF INFECTION; INCISIONS WERE FULLY HEALED. X-RAY REVEALED A 10 DEGREE ANGULATION BOTH OF THE PLATE AND THE BONE." "NO PAST MEDICAL HISTORY."

  Patient problems: Failure of Implant; Injury

  MAUDE report 10434722 ↗