EXPEDIUM VERSE 199723655Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034403069), received between Sep 26, 2019 and Jan 4, 2024 — classified as 4 injuries.

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 4, 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: ADJACENT SEGMENT PATHOLOGY COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM VERSE FENESTRATED PRODUCTS (5.5 EXP VERSE FEN SCR 6.0X55 FOR (B)(4)).

  Patient problems: Osteolysis

  MAUDE report 18446136 ↗
• InjuryJan 4, 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: ADJACENT SEGMENT PATHOLOGY. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM VERSE FENESTRATED PRODUCTS 5.5 EXP VERSE FEN SCR 6.0X55 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18446057 ↗
• InjurySep 26, 2019Break; Break

  BUSINESS UNIT: DEPUY SYNTHES SPINE. DATE J&J BECAME AWARE: (B)(6) 2019. DATE OF EVENT: (B)(6) 2019. NAME OF REPORTER: (B)(6). PRODUCT NAME: EXPEDIUM VERSE ADVANCED CORTICAL FIX FENESTRATED SCREWS. PRODUCT CODE: 2 X 199723655 (LOT: TBC ONCE ITEMS DECONTAMINATED). WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. DID THE EVENT HAPPEN DURING A PROCEDURE? NO IT HAPPENED POST PROCEDURE. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES. EVENT OUTCOME/HOW WAS IT MANAGED? REVISION SURGERY TO REMOVE BROKEN SCREWS, REPOSITION AND INSERT NEW SCREWS. DISTAL COMPONENT OF BROKEN SCREW REMAINED IN PATIENT. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? SECOND PROCEDURE. BROKEN COMPONENT OF SCREW REMAINED IN PATIENT. WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY? NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? YES, CURRENTLY BEING DECONTAMINATED BY THE ACCOUNT. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: FUSION UNDERTAKEN APPROX. (B)(6) 2018 ACROSS L5-S1. DISCECTOMY AND SCREW/ROD INSERTION. ITEMS 199723655 WERE INSERTED INTO BOTH SIDES OF S1 AS PEDICULAR FIXATION POINTS. ADVIS

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9125695 ↗
• InjurySep 26, 2019Break; Break

  BUSINESS UNIT: DEPUY SYNTHES SPINE. DATE J&J BECAME AWARE: 05/9/2019. DATE OF EVENT: (B)(6) 2019. NAME OF REPORTER: (B)(6). HOSPITAL NAME: (B)(6). PRODUCT NAME: EXPEDIUM VERSE ADVANCED CORTICAL FIX FENESTRATED SCREWS. PRODUCT CODE: 2 X 199723655 (LOT: TBC ONCE ITEMS DECONTAMINATED). WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. DID THE EVENT HAPPEN DURING A PROCEDURE? NO IT HAPPENED POST PROCEDURE. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES. EVENT OUTCOME/HOW WAS IT MANAGED? REVISION SURGERY TO REMOVE BROKEN SCREWS, REPOSITION AND INSERT NEW SCREWS. DISTAL COMPONENT OF BROKEN SCREW REMAINED IN PATIENT. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? SECOND PROCEDURE. BROKEN COMPONENT OF SCREW REMAINED IN PATIENT. WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY? NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? YES, CURRENTLY BEING DECONTAMINATED BY THE ACCOUNT. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: FUSION UNDERTAKEN APPROX. (B)(6) 2018 ACROSS L5-S1. DISCECTOMY AND SCREW/ROD INSERTION. ITEMS 199723655 WERE INSERTED INTO BOTH SIDES OF S1 AS PEDICULAR F

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9125587 ↗