EXPEDIUM 179772045SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034270166), received between Sep 12, 2022 and Jan 5, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: NEUROCOMPRESSION COMPLICATION TIME/INTERVENTION REPEAT SURGERY. THIS REPORT IS FOR ONE (1) MMSI ROD PREBENT, 5.5 X45MM, T THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4). IT IS RELATED TO (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 18456825 ↗
• InjuryJan 5, 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, NEUROCOMPRESSION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE MOSS MIAMI SI /OTHER, VIPER /OTHER, VIPER CFX FENESTRATED, VIPER CFX FENESTRATED. THIS IS REPORT 1 OF 4 FOR COMPLAINT: (B)(4).

  Patient problems: Joint Laxity; Nerve Damage

  MAUDE report 18454628 ↗
• MalfunctionSep 12, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON REPORTED ABOUT THE ROD LOOSENING EXPEDIUM VERSE. IT WAS A RESTORATION OF NON-SPECIFIC CAUSE IN TWO PATIENTS. NO DIRECT REFERRAL TO IMPLANT / INSTRUMENTS, ETC. PATIENT 2. PER THE SURGEON, ONE SZ. 6 SCREW IS DISLOCATED FROM THE REDUCTION, THEREFORE ONE SZ, 7 SCREW WAS USED. ACCORDING TO THE SURGEON THE ROD LOOSENING IS SUSPECTED TO BE CAUSED BY PATIENT WEIGHT (150KG). NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) MMSI ROD PREBENT, 5.5 X45MM, T THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15404680 ↗