EXPEDIUM 179712535Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 x 5 x 35mm · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034067544), received between Aug 28, 2024 and Aug 28, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Ambulation or Postural Difficulties1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LEGAL DOCUMENTATION, THE PATIENT SUSTAINED INJURIES DUE TO A CAR ACCIDENT ON (B)(6) 2020. SUBSEQUENTLY, ON (B)(6) 2020, PLAINTIFF THE UNDERWENT AN OCCIPUT-C3 POSTERIOR SPINAL FUSION WHERE BONE SCREWS AND TITANIUM RODS WERE PLACED IN HER CERVICAL SPINE. PATIENT HAD GOOD RECOVERY. ON (B)(6) 2020, PATIENT WAS SEEN AND X-RAYS LEFT THE IMPRESSION OF AN ¿[I]NSTRUMENTED POSTERIOR SPINAL FUSION AND POSTERIOR DECOMPRESSION FROM THE OCCIPUT THROUGH C3 FOR MANAGEMENT OF CERVICAL SPINE FRACTURES.¿ ALSO, X-RAYS OF HER RIGHT SHOULDER SHOWED A CLAVICULAR FRACTURE AND THORACIC COMPRESSION FRACTURES AT THE T5 AND T6 LEVELS. PLAINTIFF WAS DIAGNOSED WITH A ¿CLOSED STABLE BURST FRACTURE OF FIRST CERVICAL VERTEBRAE WITH ROUTINE HEALING.¿ ON (B)(6) 2020 PATIENT WAS SEEN AND WAS NOTED DOING PHYSICAL THERAPY AND WAS IMPROVING. ON (B)(6) 2020 CT SCANS OF THE CERVICAL AND THORACIC SPINE SHOWED: OCCIPUT-C3 POSTERIOR BONE FUSION WITHOUT EVIDENCE FOR HARDWARE FAILURE¿ AND FRACTURES AT THE T3-T6 LEVELS. ON (B)(6) 2020, PATIENT WAS TREATED FOR PAIN MANAGEMENT AND WAS DIAGNOSED WITH CERVICALGIA AND PAIN IN THE THORACIC SPINE. ON (B)(6) 2020 PATIENT WAS SEEN AND X-RAYS OF THE CERVICAL AND T
Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 20085855 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- 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.