EXPEDIUM 179722880Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034071046), received between Sep 28, 2017 and Apr 15, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF HARDWARE DUE TO INFECTION ON (B)(6) 2024. FOUR SCREWS, 3 LATERAL CONNECTORS, AND 7 SET SCREWS WERE REMOVED. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE UNK - SCREWS: EXPEDIUM. THIS IS REPORT 1 OF 4 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE CAPTURED IN (B)(4). ADDITIONALLY, (B)(4) CAPTURES AN INSTRUMENT MALFUNCTION THAT OCCURRED DURING THE REMOVAL SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 19107006 ↗
• MalfunctionSep 17, 2019Crack; Crack

  DEVICE REPORT FROM DEPUY (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PELVIC FIXATION PROCEDURE PERFORMED ON (B)(6) 2019. THE TIP OF THE SCREWDRIVER (279722400) BECAME STRIPPED AGAINST THE HARD BONE. BECAUSE FRAGMENTS STUCK IN THE SCREW CORE (179722880), THE SCREW WAS ALSO REMOVED AND REPLACED. THE SURGERY WAS COMPLETED WITH A LESS THAN A THIRTY (30) MINUTE SURGICAL DELAY. POSTOPERATIVE X-RAYS SHOWED THAT NO FRAGMENT HAD BEEN LEFT IN THE PATIENT'S BODY. THIS REPORT IS FOR A POLYAXLE SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9078797 ↗
• MalfunctionJun 5, 2018Break; Break

  REV T3-PELVIS, BROKEN RODS AT L5/S1; (B)(6), (B)(6) HOSPITAL (B)(6) 2018. PT IN FOR SURGERY FOR BROKEN RODS AT L5/S1 ON BOTH SIDES. EXISTING CONSTRUCT - T3-PELVIS ((B)(6) 2015). SURGEON STATED THAT THERE WAS NO OBVIOUS NON UNION. REPLACED SCREWS AND RODS, AT L4-PELVIS. ALSO NOTED THAT WHEN HE WENT TO REMOVE THE ILIAC SCREW ON THE L) SIDE, THE SCREW HEAD BROKE OFF FROM THE SHAFT. THE SURGEON LEFT THIS IN THE PATIENT AND PLACED ANOTHER SCREW IN THE PELVIS. THE RODS WERE REMOVED AND REPLACED AND JOINED TO THE REMAINING CONSTRUCT WITH AXIAL CONNECTORS.

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7568675 ↗
• InjurySep 28, 2017Break; Break

  BOTH SCREWS BROKE AFTER ABOUT 1 YEAR AFTER IMPLANTATION. A 8X80 MM WAS USED AS ILIAC SCREW, 7X45 IN S1. REVISION SURGERY WAS NECESSARY TO REGAIN A STABLE SITUATION. QUESTION: ONLY FATIGUE FRACTURE OF THE SCREW OR MATERIAL DEFECT.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6899968 ↗