QUARTEX 1149.0001Recalls & reported problems
Globus Medical, Inc. · QUARTEX Threaded Locking Cap · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889095354492), received between Apr 14, 2022 and Mar 4, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection1
- Material Separation1
- Migration1
Patient problems
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE SET SCREW ON THE LOCKING CAP HAS BACKED OUT POST-OPERATIVELY. A REVISION IS NOT SCHEDULED.
Patient problems: Failure of Implant
MAUDE report 18832597 ↗MalfunctionMar 4, 2024Migration; Migration
IMAGING TAKEN SIX WEEKS POST-OPERATIVELY IDENTIFIED THAT TWO LOCKING CAPS HAD BACKED OUT FROM THE ROD ACCEPTORS IN THE OCCIPITAL PLATE.
Patient problems: Failure of Implant
MAUDE report 18825819 ↗MalfunctionApr 14, 2022Loose or Intermittent Connection
IT WAS REPORTED THAT A REVISION WAS COMPLETED FOR 2 QUARTEX THREADED LOCKING CAPS THAT LOOSENED AT C2 AND C3, 2 MONTHS POST OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14112809 ↗
Other Posterior cervical screw system devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- CONNECTOR 79-2002Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- SYMPHONY 1020-35-112Medos International Sàrl · Posterior cervical screw system6 deaths15 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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