EXPEDIUM 179788650Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 x 6.0 x 50mm · Class 2 · Implant
All models of EXPEDIUM (291)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034081410), received between Aug 16, 2019 and Sep 22, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Slipped” (1 report).
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
Device problems
- Device Slipped1
- Loose or Intermittent Connection1
Patient problems
- No Code Available2
- Failure of Implant1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2020Device Slipped; Device Slipped
IT WAS REPORTED THAT ON UNKNOWN DATE, THERE WAS A POST-OPERATIVE DISCONNECTION WITH A FAILURE AT SCREW, ROD INTERFACE AT DISTAL END OF SCOLIOSIS CORRECTING SEGMENTAL PEDICAL SCREW CONSTRUCT. THE SURGEON SUSPECTS THAT A CERTAIN AMOUNT OF MEDIAL OR LATERAL FORCE FROM THE ROD ON THE TULIP HEAD SPLAYS HEAD ENOUGH TO ALLOW SLIPPAGE. THERE IS NO APPARENT MALFUNCTION WITH THE ROD. THE PATIENT IS CURRENTLY CHARACTERIZED AS AN ASYMPTOMATIC HARDWARE FAILURE. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2); SINGLE-INNER SETSCREW (PART # 179702000, LOT # UNKNOWN, QUANTITY 1); SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 4). THIS REPORT IS FOR ONE (1) EXP TI UNI SCREW 6MM X 50MM. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Failure of Implant; No Code Available
MAUDE report 10567796 ↗InjuryAug 16, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
REVISION FUSION: (B)(6), (B)(6) 2019. PRIMARY IMPLANT DATE: (B)(6) 2018. REVISION FOR DISLODGED RODS. SET SCREWS WERE NO LONGER IN SCREW HEADS RIGHT SIDE ROD NO LONGER STABLE CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY ONE). THIS COMPLAINT INVOLVES 11 (ELEVEN) DEVICES.
Patient problems: No Code Available
MAUDE report 8902463 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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