TOSCA Variable angle expansion screwRecalls & reported problems
SIGNUS Medizintechnik GmbH · The TOSCA Anterior Cervical Plate System consits of various sizes of bone plates and screws that are either fixed angle or variable angle. The screws are used to secure the plates to the vertebral bodies of the cervical spine through the anterior approach. The plates and screws are made from Titanium alloy Ti6Al4V, are in conformance with ASTM F136, and are supplied non-sterile. · 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 04047844002766), received between Nov 12, 2019 and Nov 12, 2019 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Mechanical Problem1
Patient problems
- Injury1
- Spinal Column Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
PATIENT WAS INITIALLY TREATED WITH AN KADEN CAGE IN C6/C7. IMPLANTATION DATE IS UNKNOWN. LATER OCCURENCE OF PAIN IN C5/C6 LED TO AN ADDITIONAL TREATMENT WITH NUBIC CAGE AND TOSCA PLATE SYSTEM WITH THE REMAINING KADEN CAGE IN C6/C7. DATE OF THIS TREATMENT IS UNKNOWN. NUBIC AND TOSCA EXPANSION SCREWS WERE FUSED. KADEN CAGE WAS NOT FUSED. DUE TO AN INSTABILITY OF THE CERVICAL COLUMN X-RAY OF (B)(6) 2019 IMAGE SHOWED A BREAKAGE OF A TOSCA SCREW IN C7. SURGEON DECIDED TO EXPLANT KADEN CAGE AND BROKEN TOSCA SCREW. THEREFORE TOSCA PLATE HAD TO BE EXPLANTED. UNDER EXPLANTATION ALL FIXATION SCREWS OF TOSCA BROKE. SEVERAL INSTRUMENTS WERE DAMAGED. PARTS OF THE BROKEN SCREWS REMAINED IN THE VERTEBRAE.
Patient problems: Injury; Spinal Column Injury
MAUDE report 9308320 ↗
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.
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