Cortical Screw, 3.5mm MDS1102X22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10812269020128), received between Oct 23, 2020 and Oct 23, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED VIA EMAIL THAT A REVISION SURGERY WAS REQUIRED TO REMOVE THE SUBJECT DEVICE. INITIAL IMPLANTATION TOOK PLACE ON (B)(6) 2017 DURING A REVISION SURGERY TO REMOVE OTHER IMPLANTS. BONE GRAFT WAS USED IN CONJUNCTION. APPROXIMATELY 17 MONTHS AFTER IMPLANTATION, THE SUBJECT DEVICE REQUIRED REMOVAL DUE TO NONUNION. TWO SHAFT SCREWS, NONLOCKED, BACKED OUT AND TWO MORE SHAFT SCREWS, NONLOCKED, MIGRATED BEYOND THE BOTTOM SURFACE OF THE PLATE. ACCORDING TO THE OPERATING SURGEON, THERE WAS MINIMAL DEFORMATION OF THE SCREW HEADS AND MINIMAL CHANGES AT THE HOLES IN THE PLATE. THERE WAS NO REPORTED BREAKAGE OF THE PLATE OR ANY OF THE SCREWS. TWO UNITS OF THE SUBJECT SCREW ARE CONSIDERED SUSPECT DEVICES.

  Patient problems: Bone Fracture(s)

  MAUDE report 10730992 ↗