NA 206.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982147257), received between Apr 18, 2019 and Sep 8, 2021 — classified as 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 18, 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.

• MalfunctionSep 8, 2021Break; Break

  IT WAS REPORTED THAT, THE CANCELLOUS BONE SCREW FELL OFF IN THE SHAFT WHILE BEING PLACED IN THE PATIENTS BONE. NO PATIENT CONSEQUENCE REPORTED AND NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN SHAFT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.0 CANCELLOUS BONE SCREW FULLY THRD/20. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439868 ↗
• MalfunctionApr 18, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HUMERUS FRACTURE PROCEDURE. DURING THE PROCEDURE, THE DOCTOR TRIED TO USE A THIRD BARREL PLATE AND COULD NOT BECAUSE ONE (1) CORTEX SCREW, ONE (1) CANCELLOUS SCREW AND ONE (1) LOCKING SCREW WERE NOT THREADING ON THE PLATE. THEY MENTIONED TO CHANGED THE PLATE, BUT THE DOCTOR FURIOUSLY TOOK THE PLATE AND WENT TO TEST IT, BUT THE PLATE WAS NOT THE PROBLEM. THE PROBLEM WAS WITH THE SCREWS THAT HAD THE THREADED DUSTED. THE THIRD BARREL PLATE WAS NOT PLACED IN THE PATIENT BECAUSE THE PATIENT'S BONE WAS VERY POROUS. THE DOCTOR PLACE THE PHILOS PLATE SINCE IT WAS SUFFICIENT TO REDUCE THE FRACTURE. THERE WAS A THIRTY (30) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NOT INJURED AND WAS DOING VERY WELL. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) THIS REPORT IS FOR ONE (1) 4.0 MM CANCELLOUS BONE SCREW FULLY THREADED/20 MM THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527121 ↗