EXPEDIUM VERSE 199723545Recalls & reported problems
Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 5.0 x 45mm · Class 2 · Implant
All models of EXPEDIUM VERSE (90)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034403250), received between Sep 5, 2018 and Nov 17, 2023 — classified as 9 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (5 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.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection5
- Break4
Patient problems
- Spinal Column Injury5
- Insufficient Information4
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2023Break; Break
DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON DISCOVERED WITH A CONTROL X-RAY THAT THE 4 CAUDAL SCREWS HAD BROKEN. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023 TO REMOVE AND REPLACE THE BROKEN SCREWS. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 5.0 X 45MM. THIS IS REPORT 4 OF 4 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18158581 ↗InjuryNov 17, 2023Break; Break
DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON DISCOVERED WITH A CONTROL X-RAY THAT THE 4 CAUDAL SCREWS HAD BROKEN. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023 TO REMOVE AND REPLACE THE BROKEN SCREWS. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 5.0 X 45MM. THIS IS REPORT 3 OF 4 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18158579 ↗InjuryNov 17, 2023Break; Break
DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON DISCOVERED WITH A CONTROL X-RAY THAT THE 4 CAUDAL SCREWS HAD BROKEN. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023 TO REMOVE AND REPLACE THE BROKEN SCREWS. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 5.0 X 45MM. THIS IS REPORT 2 OF 4 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18158578 ↗InjuryNov 17, 2023Break; Break
DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON DISCOVERED WITH A CONTROL X-RAY THAT THE 4 CAUDAL SCREWS HAD BROKEN. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023 TO REMOVE AND REPLACE THE BROKEN SCREWS. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 5.0 X 45MM. THIS IS REPORT 1 OF 4 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18158577 ↗InjurySep 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT A REVISION SURGERY ON AN EXPEDIUM VERSE CONSTRUCT WAS PERFORMED DUE TO ROD MIGRATION. SURGEON SAW DURING SURGERY, THAT A TO SMALL ROD DIAMETER WAS USED FOR THE INITIAL CONSTRUCT. SCREWS, RODS AND INNIES WERE REPLACED. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION: REVISION SURGERY DUE TO THE ROD MIGRATION. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.
Patient problems: Spinal Column Injury
MAUDE report 7847834 ↗InjurySep 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT A REVISION SURGERY ON AN EXPEDIUM VERSE CONSTRUCT WAS PERFORMED DUE TO ROD MIGRATION. SURGEON SAW DURING SURGERY, THAT A TO SMALL ROD DIAMETER WAS USED FOR THE INITIAL CONSTRUCT. SCREWS, RODS AND INNIES WERE REPLACED. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION:REVISION SURGERY DUE TO THE ROD MIGRATION. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.
Patient problems: Spinal Column Injury
MAUDE report 7847803 ↗InjurySep 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT A REVISION SURGERY ON AN EXPEDIUM VERSE CONSTRUCT WAS PERFORMED DUE TO ROD MIGRATION. SURGEON SAW DURING SURGERY, THAT A TO SMALL ROD DIAMETER WAS USED FOR THE INITIAL CONSTRUCT. SCREWS, RODS AND INNIES WERE REPLACED. PATIENT CONSEQUENCE? :YES. PATIENT CONSEQUENCE DESCRIPTION:REVISION SURGERY DUE TO THE ROD MIGRATION. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.
Patient problems: Spinal Column Injury
MAUDE report 7847754 ↗InjurySep 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT A REVISION SURGERY ON AN EXPEDIUM VERSE CONSTRUCT WAS PERFORMED DUE TO ROD MIGRATION. SURGEON SAW DURING SURGERY, THAT A TOO SMALL ROD DIAMETER WAS USED FOR THE INITIAL CONSTRUCT. SCREWS, RODS AND INNIES WERE REPLACED. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION:REVISION SURGERY DUE TO THE ROD MIGRATION. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.
Patient problems: Spinal Column Injury
MAUDE report 7847683 ↗InjurySep 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT A REVISION SURGERY ON AN EXPEDIUM VERSE CONSTRUCT WAS PERFORMED DUE TO ROD MIGRATION. SURGEON SAW DURING SURGERY, THAT A TOO SMALL ROD DIAMETER WAS USED FOR THE INITIAL CONSTRUCT. SCREWS, RODS AND INNIES WERE REPLACED. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION: REVISION SURGERY DUE TO THE ROD MIGRATION. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.
Patient problems: Spinal Column Injury
MAUDE report 7847653 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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