MERCURY 62075-050Recalls & reported problems
Spinal Elements, Inc. · Screw;Ø7.5 X 50MM MERCURY® CLASSIC POLYAXIAL SCREW · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00840606117791), received between Oct 22, 2019 and Oct 22, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Failure of Implant1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IN LATE (B)(6) 2019, PATIENT (DIAGNOSED WITH PSEUDARTHROSIS) UNDERWENT REVISION SURGERY TO REMOVE (COMPETITIVE IMPLANT HARDWARE) LEFT FRACTURED BONE SCREW AND REPLACED WITH RIGHT SIDE, UNILATERAL HARDWARE FROM L4-S1. DURING ROUTINE TWO WEEK POST-OP FOLLOW UP, RADIOGRAPHIC IMAGING DEPICTED PEDICLE BONE SCREW HEAD SEPARATION FROM RIGHT SHANK AT S1. APPROXIMATELY TWO WEEKS LATER, REVISION SURGERY WAS PERFORMED TO REMOVE REPLACE THE RIGHT S1 SCREW AND ADD SUPPLEMENTAL FIXATION (ADJACENT ROD AND ILIAC SCREW). POST-REVISION PATIENT IS REPORTEDLY DOING WELL.
Patient problems: Failure of Implant; Pain
MAUDE report 9218773 ↗
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 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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