MAYFIELD® R6367ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780025375), received between Apr 18, 2023 and Apr 18, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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.

• InjuryApr 18, 2023Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  A FACILITY REPORTED THAT DURING SPINAL SURGERY, THE RUGGLES DISTRACTION SCREW - STERILE - 12 MM (R6367A) FRACTURED INSIDE OF THE PATIENT. REPORTEDLY, THREE (3) SCREWS WERE USED, TWO (2) BENT DURING USE AND ONE FAILED, COMPLETELY FRACTURING OFF INSIDE THE PATIENT¿S BONE. THE THE DISTRACTION SCREW FRAGMENT REMAINED IN THE PATIENT AND WAS UNABLE TO BE REMOVED. FOLLOWING THE EVENT, THE SURGEON PROCEEDED WITH THE SURGERY AND LEFT THE BROKEN PIECE IN THE VERTEBRAE. THERE WAS A DELAY OF AT LEAST 30 MINUTES AND PROLONGED EXPOSURE TO ANESTHESIA DUE TO THE DELAY IN TRYING TO GET THE BROKEN PIECE OUT AS WELL AS MULTIPLE PINS HAVING TO BE OPENED DUE TO THE BENDING. IT WAS REPORTED THAT THERE WAS NO COMPLICATIONS TO THE PATIENT POST-PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16765132 ↗