EXPEDIUM VERSE 199721850Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034441948), received between Jul 22, 2019 and Mar 31, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 18, 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.

• InjuryMar 31, 2022Device Slipped; Migration; Device Slipped; Migration

  IT WAS REPORTED THAT ON AN (B)(6) 2022, THE PATIENT IS BEING BROUGHT BACK FOR A 3RD SURGERY (2ND TO ADDRESS THE SAME ISSUE). THE ROD HAS ONCE AGAIN MIGRATED IN THE TULIP HEAD SUGGESTING LOOSENING. THIS REPORT CAPTURES THE REPORTED 3RD SURGERY OF ROD MIGRATION, WHILE RELATED COMPLAINT (B)(4) CAPTURES THE REPORTED SECOND SURGERY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE SCREW 8.0 X 50 THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

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

  MAUDE report 13969120 ↗
• InjuryMar 24, 2022Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF ROD/SET SCREW . THE ROD LOOSENS WITHIN THE TULIP HEAD. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS REPORT IS RELATED TO (B)(4) WHICH CAPTURES THE REPORTED EVENT OF PATIENT REQUIRING 3RD SURGERY AS THE ROD HAS ONCE AGAIN MIGRATED IN THE TULIP HEAD. THIS IS REPORT 2 OF 3 FOR (B)(4).

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

  MAUDE report 13896169 ↗
• InjuryJul 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING THE INSERTION OF ONE OF THE 8 MM SCREWS, A PEDICLE FRACTURE HAPPENED. THE SURGEONS MANAGED TO CORRECT THE SPONDYLOLISTHESIS FROM STAGE 2 TO STAGE 1 WITH AN ANTERIOR OSTEOPHYTE ON L4 THAT COULD NOT BE REMOVED DURING THE SURGERY. THERE WAS A SURGICAL DELAY OF 20 MINUTES. THE PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICES.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8812884 ↗
• InjuryJul 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT REVISION SURGERY OR THE ROD REDUCTION, THERE WAS A PULL-OUT OF TWO (2) SCREWS WITH 7 MM DIAMETER WHICH WERE REMOVED AND REPLACED WITH TWO (2) 8 MM SCREWS. DURING THE INSERTION OF ONE OF THE 8 MM SCREWS, A PEDICLE FRACTURE HAPPENED. THE CONSTRUCT CONSISTS NOW OF FIVE (5) SCREWS (2 SCREWS IN S1, 1 SCREW IN L5 AND 2 SCREWS IN L4) CONNECTED WITH THE SFX CONNECTOR. THE SURGEONS MANAGED TO CORRECT THE SPONDYLOLISTHESIS FROM STAGE 2 TO STAGE 1 WITH AN ANTERIOR OSTEOPHYTE ON L4 THAT COULD NOT BE REMOVED DURING THE SURGERY. THERE WAS A SURGICAL DELAY OF 20 MINUTES. THE PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES.

  Patient problems: Injury

  MAUDE report 8812599 ↗