EXPEDIUM 179722050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034070087), received between Sep 5, 2018 and Oct 1, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DATE: (B)(6) 2019, 4 PM. EVENT DESCRIPTION: BROKEN RODS AND METALLOSIS. DATE J&J BECAME AWARE: (B)(6) 2019, 4 PM. NAME OF REPORTER: (B)(6). HOSPITAL NAME: (B)(6). HOSPITAL TOWN: (B)(6). PRODUCT: COCR 5.5 MM ROD, DI EXPEDIUM SCREWS, UNITISED SET SCREWS, CONNECTOR LOT/BATCH/EXP: UNKNOWN. PRODUCT NUMBER: 179774555, 179722050, 179722644, 198769480. DID THE EVENT HAPPEN DURING A PROCEDURE? NO. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. EVENT OUTCOME/HOW WAS IT MANAGED? RODS REPLACED, BLOOD WAS NOT USED WHEN SEDIMENT DISCOVERED. WAS THERE A PATIENT IMPACT OR WAS THE PROCEDURE DUE TO THE FAILURE? PATIENT HAS METALLOSIS. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? HOPEFULLY IF RETURNED FROM STERILISATION SUCCESSFULLY. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: THE PATIENT WAS UNDERGOING REVISION SURGERY IN WHICH THE COCR RODS HAD SNAPPED ON BOTH THE LEFT AND THE RIGHT SIDE. THE SURGEON REMOVED SET SCREWS, RODS CONNECTORS AND SCREWS. UPON REMOVAL OF THE METAL WORK, THERE WAS CONSIDERABLE METALLOSIS ON THE PATIENT¿S TISSUE. THE ANESTHETIST WAS USING CELL S

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9140232 ↗
• InjurySep 5, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2018, THE TLIF SURGERY FOR LUMBAR SPONDYLOLISTHESIS WAS PERFORMED BY USING THE EXPEDIUM SYSTEM. THE FIXED SITE WAS L5 ¿ S1. DURING THE SURGERY, DUE TO AN EXCESSIVE INSERTING TORQUE, THE TIP OF THE DRIVER ((B)(4)) GOT BROKEN AND THE BROKEN TIP WAS LEFT IN THE HEAD OF THE SCREW (EITHER (B)(4)), WHICH RESULTED IN THE INSERTION FAILURE. THE SCREW IN QUESTION WAS EXTRACTED AND THEN A NEW SCREW WAS INSERTED. NO BROKEN PIECES WERE FOUND LEFT IN THE PATIENT¿S BODY UNDER THE X-RAY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A 60-MINUTE DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGEON HAS REQUESTED US TO MAKE AN IN-DEPTH INVESTIGATION INCLUDING A POSSIBILITY OF METALLIC FATIGUE.

  Patient problems: Not Applicable

  MAUDE report 7847684 ↗