EXPEDIUM 187702635Recalls & reported problems
Depuy Spine, LLC · EXPEDIUM ANTERIOR SPINE SYSTEM MONOAXIAL SCREW 5.5 x 6 x 35mm · Class 2 · Implant
All models of EXPEDIUM (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034138572), received between Nov 21, 2017 and Nov 21, 2017 — classified as 3 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
Device problems
- Loose or Intermittent Connection3
Patient problems
- Failure of Implant3
- Injury3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2017Loose or Intermittent Connection; Loose or Intermittent Connection
ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT SET SCREWS (PART#: UNK) FIXED AT CAUDAL END WERE LOOSENED AND THAT RODS HAD MOVED IN UPPER POSITION, RESULTING IN LOSS OF THE CORRECTIVE FORCE. THE SURGEON DECIDED TO CONDUCT RE-OPERATION NEXT WEEK BECAUSE SUCH LOOSENED SET SCREWS MIGHT CONTACT THE HEART OF THE PATIENT. HE WILL USE NON-J&J REPLACEMENTS AT THE RE-OPERATION SCHEDULED NEXT WEEK.
Patient problems: Failure of Implant; Injury
MAUDE report 7049612 ↗InjuryNov 21, 2017Loose or Intermittent Connection; Loose or Intermittent Connection
ON(B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT SET SCREWS (PART#: UNK) FIXED AT CAUDAL END WERE LOOSENED AND THAT RODS HAD MOVED IN UPPER POSITION, RESULTING IN LOSS OF THE CORRECTIVE FORCE. THE SURGEON DECIDED TO CONDUCT RE-OPERATION NEXT WEEK BECAUSE SUCH LOOSENED SET SCREWS MIGHT CONTACT THE HEART OF THE PATIENT. HE WILL USE NON-J&J REPLACEMENTS AT THE RE-OPERATION SCHEDULED NEXT WEEK.
Patient problems: Failure of Implant; Injury
MAUDE report 7049486 ↗InjuryNov 21, 2017Loose or Intermittent Connection; Loose or Intermittent Connection
ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT SET SCREWS (PART#: UNK) FIXED AT CAUDAL END WERE LOOSENED AND THAT RODS HAD MOVED IN UPPER POSITION, RESULTING IN LOSS OF THE CORRECTIVE FORCE. THE SURGEON DECIDED TO CONDUCT RE-OPERATION NEXT WEEK BECAUSE SUCH LOOSENED SET SCREWS MIGHT CONTACT THE HEART OF THE PATIENT. HE WILL USE NON-J&J REPLACEMENTS AT THE RE-OPERATION SCHEDULED NEXT WEEK.
Patient problems: Failure of Implant; Injury
MAUDE report 7049423 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 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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