EXPEDIUM 179722155Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 x 10 x 55mm · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034070179), received between Aug 10, 2023 and Aug 10, 2023 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Slipped1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2023Device Slipped; Device Slipped
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY ON (B)(6) 2018. IN THE SURGERY, L4 TO S WERE FIXED WITH MATRIX IMPLANTS. POSTOPERATIVELY, ADJACENT SEGMENT DISEASE (ASD) OCCURRED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. DURING THE REVISION SURGERY, THE MATRIX SCREW AT LEFT-SIDE S WAS FOUND TO BE LOOSE, AND WAS TO BE REPLACED WITH AN EXPEDIUM SCREW DI10.0×55. DURING INSERTION OF THE EXPEDIUM SCREW, THE TIP OF THE SCREWDRIVER WAS DAMAGED AND CAUGHT INSIDE THE CORE, MAKING IT IMPOSSIBLE TO PROCEED WITH SCREW INSERTION. THE SCREW WAS EXTRACTED AND ANOTHER EXPEDIUM SCREW (DI10.0×45) WAS INSERTED. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR AN EXP DI POLY SCREW 10X55MM TI. THIS IS REPORT 1 OF 1 AND CAPTURES THE INTRAOPERATIVE INCIDENT. THE CAUSE OF THE REVISION SURGERY IS CAPTURED UNDER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17503483 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.