MERCURY 63485-090Recalls & reported problems
Spinal Elements, Inc. · 8.5mm x 90mm Iliac Polyaxial Screw · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840606101295), received between Nov 25, 2020 and Mar 7, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Mechanical Problem1
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
PATIENT UNDERWENT FOUR LEVEL SPINAL FUSION SURGERY ON (B)(6) 2024 L2- PELVIS. DURING ROUTINE SIX WEEK FOLLOW UP, IT WAS NOTED THAT THE TULIP HEAD SEPARATED FROM THE ILIAC BONE SCREW AND THE S1 BONE SCREW. PATIENT IS ASYMPTOMATIC AND THERE IS NO PLAN FOR REVISION SURGERY AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 18858779 ↗MalfunctionNov 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
PATIENT RECEIVED A SPINAL FUSION SURGERY (PLIF) WITH BILATERAL FIXATION FROM T10-PELVIS. INITIAL SURGERY DATE WAS (B)(6) 2020. DURING ROUTINE FOLLOW UP VISIT 6 WEEKS POST-OPERATIVELY, RADIOGRAPHS DEPICTED A TULIP/HEAD SEPARATION FROM THE ILIAC BOLT ON THE LEFT SIDE. PATIENT IS ASYTOMATIC. THERE IS NO PLAN FOR REVISION UNLESS PATIENT PRESENTS WITH NON-UNION AT L5-S1, OR SACRAL FRACTURE.
Patient problems: Failure of Implant
MAUDE report 10906301 ↗
Other Thoracolumbosacral Pedicle Screw System devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- 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 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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