EXPEDIUM VERSE 199723745Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705034402918), received between Feb 12, 2019 and Mar 6, 2024 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2024Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY WAS PERFORMED ON (B)(6) 2024. L5/S FUSION, VERSE 1 INTERVERTEBRAL. THE CAGE IS A COMPETITOR¿S PRODUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE ORIGINAL PROCEDURE, ON (B)(6) 2024, THE SALES REP WAS INFORMED THAT THE SET SCREW IN QUESTION HAD BACKED OUT, AND THE L5 LEFT SET SCREW HAD COME OFF. THE CAUSE IS UNKNOWN, A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 7.0 X 45MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18848002 ↗
• 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: NEUROCOMPRESSION, COMPLICATION TIME/INTERVENTION, REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 7.0 X 45MM. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 18462956 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION (REMOVAL OF HARDWARE) (B)(6) 2023 DUE TO INFECTION AND 3 BROKEN SCREWS INSITU. HARDWARE SENT TO PATHOLOGY FOR TESTING. SURGEON NOT CONCERNED REGARDING BROKEN HARDWARE, SUBMITTING CUSTOMER COMPLAINT AS PER PROTOCOL. THIS REPORT IS FOR ONE (1)5.5 EXP VERSE FEN SCR 7.0X45 THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18139513 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION (REMOVAL OF HARDWARE) ON (B)(6) 2023 DUE TO INFECTION AND 3 BROKEN SCREWS INSITU. HARDWARE SENT TO PATHOLOGY FOR TESTING. SURGEON NOT CONCERNED REGARDING BROKEN HARDWARE, SUBMITTING CUSTOMER COMPLAINT AS PER PROTOCOL. THIS REPORT IS FOR ONE (1)5.5 EXP VERSE FEN SCR 7.0X45 THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18139363 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION (REMOVAL OF HARDWARE) (B)(6) 2023 DUE TO INFECTION AND 3 BROKEN SCREWS INSITU. HARDWARE SENT TO PATHOLOGY FOR TESTING. SURGEON NOT CONCERNED REGARDING BROKEN HARDWARE, SUBMITTING CUSTOMER COMPLAINT AS PER PROTOCOL. THIS REPORT IS FOR ONE (1)5.5 EXP VERSE FEN SCR 7.0X45 THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18139361 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION (REMOVAL OF HARDWARE) OCTOBER 26, 2023 DUE TO INFECTION AND 3 BROKEN SCREWS INSITU. HARDWARE SENT TO PATHOLOGY FOR TESTING. SURGEON NOT CONCERNED REGARDING BROKEN HARDWARE, SUBMITTING CUSTOMER COMPLAINT AS PER PROTOCOL. THIS REPORT IS FOR ONE (1)5.5 EXP VERSE FEN SCR 7.0X45 THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18139357 ↗
• MalfunctionJun 30, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SPINE REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT A BROKEN PEDICLE SCREW WAS FOUND IN A LYING CONSTRUCT. THE TIP OF THE BROKEN SCREW WAS LEFT IN THE PATIENT. NO ADDITIONAL TIME OR SURGERY SPENT TO REMOVE THIS TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS REPORTED AS OKAY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 7.0X45 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243402 ↗
• MalfunctionAug 23, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PSF SURGERY ON (B)(6) 2022, WHILE LOCKING IN THE SET SCREWS UPON TIGHTENING, THE SURGEON NOTICED THAT THE SET SCREW HAD SHEARED THE THREADS IN THE SCREW. THE SCREW WAS REPLACED ALONG WITH THE ROD AND 3X SET SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER A SURGICAL DELAY OF 20 MINUTES. NO FRAGMENTS WERE GENERATED, AND THERE WAS NO REPORTED ADVERSE PATIENT OUTCOME. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 7.0 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274810 ↗
• MalfunctionJun 5, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PEDICLE FRACTURE BREAKAGE. THE SURGEON INSERTED THE SCREWS WITHOUT I/I CONTROLLED. SCREWS WERE ALL IN PLACE, WHEN THE SURGEON WAS ABOUT TO USE THE SRI VERSE DISTRACTOR, HE CONNECTED THE SRI DISTRACTION SLEEVE APAU0231, LOCKED THEM WHICH MAY HAVE GENERATED THE BREAKAGE. CONCOMITANT DEVICE REPORTED: UNKNOWN RI VERSE DISTRACTOR (PART # UNKNOWN, LOT # UNKNOWN , QUANTITY 1), UNKNOWN SRI DISTRACTION SLEEVE (PART # APAU0231, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10123945 ↗
• InjuryMar 16, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO FRACTURED VERSE SCREWS AT THE S1 LEVEL OCCURRED. REVISION SURGERY WAS PERFORMED BY REMOVING ALL UNITIZED SET SCREWS (X6), RODS 65MM TI (X2). PART OF THE BROKEN 7MM VERSE SCREWS (X2) THE DISTAL SCREW SHANKS REMAINED IN THE VERTEBRAL BODY OF S1. THE L4 & 5 SCREWS REMAINED IN THE PATIENT AND REUSED FOR THE REVISION PROCEDURE. 2X S2AI 8X80MM SCREWS WERE INSERTED AND CONNECTED WITH A COCR ROD TO THE EXISTING L4 AND 5 SCREWS. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 7.0X45. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 9836413 ↗
• InjuryMar 16, 2020Break; Entrapment of Device; Break; Entrapment of Device

  CONCOMITANT DEVICE REPORTED: 5.5 EXP VERSE UNITIZED SET SCR (PART# 199721001, LOT# VH1321, QUANTITY 2). 5.5 EXP VERSE UNITIZED SET SCR (PART# 199721001, LOT# VP1211, QUANTITY 2). 5.5 EXP VERSE UNITIZED SET SCR (PART# 199721001, LOT# VE1112, QUANTITY 1). 5.5 EXP VERSE UNITIZED SET SCR (PART# 199721001, LOT# VP1331, QUANTITY 1). 2 PK TI ROD PREBENT, 5.5 X65MM (PART# 179772065, LOT# BDMJ3T4, QUANTITY 2). 5.5 EXP VERSE FEN SCR 7.0X45 (PART # 199723745, LOT # 112584, QUANTITY 1).

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 9836412 ↗
• InjuryFeb 12, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A REVISION SURGERY 2 OF 4 VERSE INNIES WERE FOUND LOOSE BESIDE THE CONSTRUCT AND 4 VERSE SCREWS SEEMED LOOSE AS WELL. ALREADY IN THE REOP X-RAY, THE INNIES SEEMED NOT TIGHTENED AND THE SCREWS LOOSE.

  Patient problems: No Code Available

  MAUDE report 8333640 ↗
• InjuryFeb 12, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A REVISION SURGERY 2 OF 4 VERSE INNIES WERE FOUND LOOSE BESIDE THE CONSTRUCT AND 4 VERSE SCREWS SEEMED LOOSE AS WELL. ALREADY IN THE REOP X-RAY THE INNIES SEEMED NOT TIGHTENED AND THE SCREWS LOOSE.

  Patient problems: No Code Available

  MAUDE report 8333213 ↗