EXPEDIUM 179922000Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM DUAL INNER SET SCREW 6.35 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034088907), received between Dec 2, 2022 and Feb 22, 2023 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Migration3
Patient problems
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 22, 2023Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2023 SURGEON SENT A SECOND TEXT SHOWING IMAGE OF 6.35 DI SET SCREW SLIPPING OFF THE ROD OF A PEDIATRIC DEFORMITY PATIENT. THIS REPORT IS FOR ONE (1) EXP 635 TI DI SETSCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16421386 ↗InjuryFeb 22, 2023Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON SENT TEXT WITH PICTURE OF PATIENT FILMS SHOWING SLIPPAGE OF THE ROD ON A PEDIATRIC SCOLIOSIS PATIENT. THE DISTAL SCREW OF THE 6.35 WITH COCR RODS AND DI SET SCREWS SLIPPED OFF THE ROD. THIS REPORT IS FOR ONE (1) EXP 635 TI DI SETSCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Failure of Implant
MAUDE report 16419905 ↗InjuryDec 2, 2022Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED WITH AN EXPEDIUM 6.35 DISTAL UNIPLANAR SCREW WITH DI SET SCREW THAT SLIPPED AND DISLODGED FROM ROD CONSTRUCT. THE PATIENT PRESENTED WITH NO PAIN, BUT A REVISION SURGERY WAS PERFORMED TO REPLACE SCREW/ROD CONSTRUCT. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM DUAL INNER SET SCREW 6.35. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 15904269 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
- CD HORIZON® Spinal System 5540030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis230 reports
- CD HORIZON® Spinal System 7578302Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis122 reports
- EXPEDIUM 179762480Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis114 reports
- ReLine 13550000Nuvasive, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis55 reports
- CD HORIZON® Spinal System 5440030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis50 reports
- EXPEDIUM 179712640Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis28 reports
- EXPEDIUM VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
- EXPEDIUM 179788635Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis18 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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