EXPEDIUM 179772095SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034270333), received between Jan 8, 2024 and Oct 22, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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.

• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: 1. WHAT WAS THE REASON FOR THE SURGERY THAT OCCURRED ON THE (B)(6)? REOPEATION OF PSEUDOARTHROSIS L5/S1. 2. WHAT DEVICES WERE REMOVED ON THE (B)(6) 2024? REMOVAL OF THE VIPER CFX CORTICAL FIX SCREW. 3. WHAT WAS THE REASON FOR REMOVING THESE DEVICES? WHY THE SCREWS WHERE LOSSENING. THAT WAS THE REASON FOR THE PSEUDOARTHROSIS.

  Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 20505683 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: 1. WHAT WAS THE REASON FOR THE SURGERY THAT OCCURRED ON THE (B)(6)? REOPEATION OF PSEUDOARTHROSIS L5/S1. 2. WHAT DEVICES WERE REMOVED ON THE (B)(6) 2024? REMOVAL OF THE VIPER CFX CORTICAL FIX SCREW. 3. WHAT WAS THE REASON FOR REMOVING THESE DEVICES? WHY THE SCREWS WHERE LOSSENING. THAT WAS THE REASON FOR THE PSEUDOARTHROSIS.

  Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 20505454 ↗
• InjuryJan 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  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: IMPLANT FAILURE. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM PRE-BENT SPINAL ROD 5.5 X 95MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18466244 ↗
• 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: INSTABILITY. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM PRE-BENT SPINAL ROD 5.5 X 95MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 18465912 ↗