NA 626677SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327088762), received between Jul 28, 2020 and Aug 20, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Fracture; Device Dislodged or Dislocated

  It was reported that, severe pain was observed following the wearing of a water pack. An X-ray shows a fracture of the osteosynthesis hardware with displacement resulting from the fracture.Clinical outcome: Surgical intervention. Actions taken for the patient: Excision, bacterial culture, new osteosynthesis, probabilistic antibiotic therapy.

  Patient problems: Pain

  MAUDE report 50355991 ↗
• MalfunctionMar 6, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "FRACTURE OF THE 2 BONES OF HIS LEFT FOREARM OSTEOSYNTHESIZED BY ULNAR AND RADIAL PLATES PLACED ON (B)(6) 2024 ON (B)(6) 2024, CALLUS FRACTURE ON THE RADIUS AND A FRACTURE OF THE OSTEOSYNTHESIS PLATE REINTERVENTION ON (B)(6) 2025 WITH REMOVAL OF THE PLATE AND FITTING OF ANOTHER, LONGER RADIAL PLATE"

  Patient problems: Bone Fracture(s)

  MAUDE report 21536474 ↗
• InjuryDec 13, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "AFTER SURGERY FOR ULNA FRACTURE, THE PLATE BROKE."

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18318230 ↗
• InjuryNov 15, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A FEW DAY AFTER THE SURGERY THE PLATE FRACTURED. THE FRACTURED PLATE WAS REMOVED AND REPLACED WITH TWO PLATES.

  Patient problems: Failure of Implant

  MAUDE report 15797400 ↗
• InjuryNov 17, 2020Fracture; Fracture

  AS REPORTED: "A PATIENT WHO HAD IMPLANTED THE PALATE BEFORE, TWISTED HIS/HER HAND, COMPLAINED OF PAIN. CONFIRMING THAT THE PLATE WAS BROKEN, THE BROKEN PLATED WAS REPLACED WITH A COMPRESSION PLATE ON (B)(6) 2020."

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 10855885 ↗
• InjurySep 16, 2020Fracture; Fracture

  AS REPORTED: "(B)(6) 2020 FIRST SURGERY. HE COMPLAINED OF PAIN AFTER THE OPERATION AND VISITED THE HOSPITAL ON (B)(6). THE PLATE WAS BROKEN AT THE SCREW NEAR THE FRACTURE. PATIENT ACTIVITY WAS HIGH. DOCTOR'S VIEW: "I DON'T KNOW WHY IT BREAKS.""

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 10542442 ↗
• InjuryJul 28, 2020Fracture; Fracture

  IT WAS REPORTED: ON (B)(6) , THE PRODUCT WAS FIXED WITH A FRACTURE OF THE PROXIMAL ULNA. THE PATIENT RESUMED DAILY ACTIVITIES A FEW DAYS AFTER SURGERY. ON(B)(6) , THE PATIENT COMPLAINED OF PAIN. WHEN I TOOK AN X-RAY, THE PLATE WAS BROKEN.

  Patient problems: Failure of Implant; Implant Pain; Injury; Pain

  MAUDE report 10332180 ↗