EXPEDIUM VERSE 199721745Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705034442105), received between Feb 26, 2019 and Sep 20, 2024 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON SEPTEMBER 8, 2024, AN EXPEDIUM SYSTEM IS USED WITH A 5.5MM BAR WITH A USS ILIOSACRAL SYSTEM THAT IS DESIGNED FOR 6.0MM BARS: LEFT AND RIGHT S2 CONNECTORS FOR 6MM BARS AND 5.5MM BAR. THE SCREW IS SENT MARKED, THE SCREW REMAINS WITH THE HEAD BLOCKED, THE SCREWDRIVER CANNOT BE CONNECTED TO EXTRACT THE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268043 ↗
• 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 SCREW 7.0 X 45 THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18139352 ↗
• 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 SCREW 7.0 X 45 THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18139329 ↗
• MalfunctionJul 13, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE SURGEON HAD PLACED ALL SCREWS, INSERTED A TI ROD AND COCR ROD, AND BEGAN INSERTION OF THE CORRECTION CLOSER SCREWS FROM THE CAUDAL SIDE. ON THE SIDE WITH THE COCR ROD, THE CORRECTION SCREW PLUGS JUMPED IN THE THREAD ON THE 2ND EXP VERSE SCREW, DAMAGING THE THREAD IN THE TULIP OF THE SCREW. THE SAME EVENT OCCURRED WITH THE 4TH SCREW, BOTH SCREWS REQUIRED REPLACEMENT. THE ROD HAD TO BE REMOVED IN ORDER TO REPLACE THE SCREWS. AFTER THIS EVENT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH REPLACEMENT PRODUCTS. THERE WAS A SURGICAL DELAY OF 30-40 MINUTES. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR A EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 7.0 X 45MM. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15004538 ↗
• MalfunctionNov 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775823 ↗
• InjuryJul 26, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON REVISED AN L4/5 FUSION. THE HARDWARE (EXPEDIUM VERSE & MATRIX X-LINK) WAS ALL LOSING DUE TO INFECTION AND NONUNION. ONE OF THE LOCK CAPS HAD COME OFF AS WELL. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 7.0 X 45. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12225045 ↗
• InjuryJul 26, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON REVISED AN L4/5 FUSION. THE HARDWARE (EXPEDIUM VERSE & MATRIX X-LINK) WAS ALL LOSING DUE TO INFECTION AND NONUNION. ONE OF THE LOCK CAPS HAD COME OFF AS WELL. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 7.0 X 45. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12225036 ↗
• InjuryJul 26, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON REVISED AN L4/5 FUSION. THE HARDWARE (EXPEDIUM VERSE & MATRIX XLINK) WAS ALL LOSING DUE TO INFECTION AND NONUNION. ONE OF THE LOCK CAPS HAD COME OFF AS WELL. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE SCREW 7.0 X 45. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12225010 ↗
• InjuryJul 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE ROD THAT WAS BROKEN BILATERALLY AND THE DISTAL SCREWS WERE LOOSENED. BROKEN ENDS OF ROD CATALOG # 1797-62-480, VERSE SCREW, 1997-21-750 X QTY 1, VERSE SCREW 1997-21-745 X QTY 1 AND 9.0X90MM SAI SCREWS 1797-04-990 X QTY 2 WERE ALL REMOVED TO REVISE. A 12.0X100MM SCREW, 1797-12-399 WAS REMOVED WITH PLIERS DUE TO THE FIRST OF TWO SCREWDRIVER TIPS BREAKING. THIS SCREW WAS NOT RECOVERED TO RETURN. THERE WERE NO FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WERE SURGICAL DELAY. THE PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8821692 ↗
• InjuryJul 22, 2019Migration; Migration

  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 7MM DIAMETER WHICH WERE REMOVED AND REPLACED WITH TWO (2) 8MM SCREWS. DURING THE INSERTION OF ONE OF THE 8MM 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: No Code Available

  MAUDE report 8812819 ↗
• InjuryJul 22, 2019Migration; Migration

  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: No Code Available

  MAUDE report 8812434 ↗
• InjuryJul 18, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING INSERTION OF THE INNIE, THE INNIE DID NOT ALIGN PROPERLY AND POSITIONED ITSELF INTO A DISPLACED PART OF SCREWS´S THREAD. THERE WAS NO SURGICAL DELAY AND THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8803895 ↗
• InjuryFeb 26, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE A SURGERY ON (B)(6) 2019, DR. (B)(6) BECAME AWARE THAT THE INNER THREAD OF SCREW WAS DEFECTIVE. THE SURGEON HAD TO REMOVE THE SCREW AND ROD, BECAUSE THE LOCKING SCREW COULD NOT SCREW IN. A NEW SCREW HAS BEEN INSERTED AND A SURGERY DELAY OF 30 MIN OCCURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8370962 ↗