NA 50-20412Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 37613154184171), received between Aug 10, 2018 and Mar 18, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Fracture

  IT WAS REPORTED THAT A PATIENT DEVELOPED OSTEOMYELITIS WITH A NON UNION FRACTURE AND A SCREW WAS BROKEN.

  Patient problems: Unspecified Infection

  MAUDE report 24629631 ↗
• InjuryJun 19, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR A FRACTURED JAW. POST-OPERATIVELY THE PATIENT PRESENTED WITH POSSIBLE INFECTION (PAIN, ABCESS) ON RIGHT PARASYMPHYSIS AREA. THE SURGEON REMOVED THE HARDWARE ON PARASYMPHYSIS BUT DID NOT RE-PLATE AS THE FRACTURE APPEARED HEALED. FOLLOWING THIS PROCEDURE, THE PATIENT PRESENTED WITH PAIN AND HAD A NON-UNION AND WAS BROUGHT BACK IN FOR FIXATION OF PARASYMPHYSIS. THERE WAS NO SIGN OF INFECTION AT THE TIME OF RE-FIXATING PATIENT'S JAW. THIS RECORD PERTAINS TO THE SCREWS THAT WERE USED.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain; Unspecified Infection

  MAUDE report 10173959 ↗
• MalfunctionAug 10, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE CASE THE HEAD OF THE BONE SCREW BROKE OFF WHILE BEING TIGHTENED. NO MEDICAL INTERVENTION NOR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7772592 ↗