EXPEDIUM 179712755Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034067926), received between Jul 21, 2021 and Jan 8, 2024 — classified as 3 injuries, 1 malfunction.

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.

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

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: ADJACENT SEGMENT PATHOLOGY, INSTABILITY, OTHER COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER, EXPEDIUM POLYAXIAL AND EXPEDIUM 5.5 PRODUCTS THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; Joint Laxity; Osteolysis

  MAUDE report 18464434 ↗
• InjuryJan 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: ADJACENT SEGMENT PATHOLOGY, IMPLANT FAILURE . COMPLICATION TIME/INTERVENTION REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND EXPEDIUM POLYAXIAL PRODUCTS (SI POLYAXL SCREW 7 X 55MM FOR (B)(4).

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 18443116 ↗
• MalfunctionNov 4, 2022Break; Device Slipped; Break; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL PROCEDURE ON (B)(6) 2022, SCREW LOOSENING OF L2 WITH BROKEN SCREWHEAD AT RIGHT SIDE L2 OCCURRED INTRAOPERATIVELY DURING AN EXTENSION OF A CONSTRUCT FROM L2-S1 TO TH1. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 55MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735821 ↗
• InjuryJul 21, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED TO EXTEND THE CONSTRUCT UP. UPON OPENING, IT WAS NOTICED THAT METALLOSIS HAD OCCURRED. THE HEADS OF THE PEDICLE SCREWS AT T11 AND T12 ON THE RIGHT HAD DISLODGED AND BROKEN OFF OF THE SCREWS. IT WAS ALSO OCCURRED WITH THE LEFT SACRAL SCREW. THE PREVIOUS CONSTRUCT WAS FROM T10-PELVIS. THIS REPORT IS FOR ONE (1) SI POLYAXIAL SCREW 5.5 X 7 X 55MM. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12205028 ↗