Cannulated Screw System + 04.353.126Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810040630774), received between Apr 8, 2024 and Apr 8, 2024 — classified as 1 death.

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.

• DeathApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED AFTER FURTHER INVESTIGATION, PROVIDED BY USER FACILITY: PATIENT PRESENTED TO ED WITH A RIGHT TRI MALLEOLAR ANKLE FRACTURE & LARGE POSTERIOR FRAGMENT WHICH OCCURRED DURING AN MVA. PATIENT WAS STABLE AND RECEIVED MEDICAL CLEARANCE PRIOR TO PROCEEDING WITH SURGERY. POSTERIOR MALLEOLUS FRACTURE WAS ADDRESSED FIRST WHICH WAS REDUCED AND PLATED IN AN ANTI-GLIDE TECHNIQUE WITH A SYNTHES POSTERIOR PLATE. THE FIBULA WAS THEN PLATED USING A SYNTHES FIBULAR PLATE, ALIGNMENT AND LENGTH WERE MAINTAINED. SECOND INCISION OVER THE MEDIAL MALLEOLUS WAS MADE WHERE 2 2.5MM SYNTHES CANNULATED SCREWS WERE PLACED TO FIX THE ANTERIOR COLLICULUS FRAGMENT. AFTER ADDRESSING THE FRACTURES, REPAIR WAS CONFIRMED ON FLUOROSCOPIC IMAGING AND ALL WOUNDS WERE IRRIGATED AND HAD VANCOMYCIN POWDER PLACED IN THEM. PATIENT WAS PLACED IN A SUGAR TONG SPLINT AND WAS TRANSFERRED TO PACU AFTER SURGERY IN STABLE CONDITION. THERE WERE NO SURGICAL DELAYS OR CHANGES FROM PRE-OP INDICATION FOR SURGERY. STRATEGY AND APPROACH FOR SURGERY STAYED THE SAME THROUGHOUT. ALL FRACTURE SITES WERE CLEARLY INDICATED ON PREOP IMAGING. PATIENT'S POST-OP BEHAVIOR WAS NORMAL. PROPER PAIN MANAGEMENT AND DVT PROPHYLAXIS WAS PROVIDED. DIS

  Patient problems: Insufficient Information

  MAUDE report 19059941 ↗