QUINTEX SC493TRecalls & reported problems
Aesculap AG · QUINTEX CONSTRAINED SCREW 4.5X17MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 04046963814137), received between Feb 8, 2022 and Feb 8, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Compatibility Problem” (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
- Compatibility Problem1
- Mechanical Jam1
Patient problems
- Failure of Implant1
- 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.
InjuryFeb 8, 2022Compatibility Problem; Mechanical Jam; Compatibility Problem; Mechanical Jam
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SC493T-QUINTEX CONSTRAINED SCREW 4.5X17MML. ACCORDING TO THE COMPLAINANT, THE QUINTEX SCREW WAS NOT LOCKING INTO THE PLATE. IT ALSO WOULD NOT BACK OUT AND A SCREW REMOVAL INSTRUMENT WAS USED TO LIFT THE PLATE OUT WITH THE SCREW STILL IN IT. THIS OCCURRED DURING A REVISION ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) PROCEDURE. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE SURGERY WAS DELAYED BY ABOUT 45 MINUTES. IT WAS NOTED THAT THE SURGERY WAS SUCCESSFUL AFTER A LONGER PLATE WAS IMPLANTED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: SC512T - 22 MM PLATE; SC403T - CONSTRAINED SCREW 4/16MM.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 13487095 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Elegance® Anterior Cervical Plate 53430353Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430108Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430114Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430240Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430236Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page