C-CURVE B20520017Recalls & reported problems
Medicrea International · C-Curve Screws Ø3.5mm x L17mmX2 · Class 2 · Implant
Data updated Oct 18, 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 03613720275671), received between Oct 15, 2025 and Jun 25, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING 3-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION FOR INFLAMMATORY DISC DISEASE AT C4-C5, C5-C6, AND C6-C7 WITH IMPLANTATION OF A C-CURVE INTERSOMATIC EXPANDABLE CAGE AND SCREWS FOR INFLAMMATORY DISC DISEASE. IT WAS REPORTED THAT A SCREW BROKE AT ITS UPPER END DURING IMPLANTATION. IT WAS ALSO REPORTED THAT THE SURGEON DID NOT USE THE SQUARE TIP BEFOREHAND AS RECOMMENDED IN THE OPERATIVE TECHNIQUE, AND THAT THE PRODUCT WAS NOT UTILIZED ACCORDING TO THE INSTRUCTIONS FOR USE/LABELING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25621073 ↗MalfunctionMay 6, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR HERNIA. IT WAS REPORTED THAT A SCREW BROKE DURING INSERTION IN THE VERTEBRAL BODY. IT WAS REPORTED THAT NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TYPE OF THERAPY INVOLVED DURING THE EVENT WAS CERVICAL THERAPY AT C5-C6 LEVELS. THERE WAS NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25096401 ↗MalfunctionOct 15, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS DISCOPATHY. IT WAS REPORTED THAT, THE HEAD OF THE SCREW BROKE AT THE LAST TIGHTENING. THE LEVELS IMPLANTED WERE C4-C5. FRAGMENT OF BROKEN SCREW WAS LEFT INSIDE PATIENT BODY. PROCEDURE PERFORMED WAS FUSION AND FIXATION. THERE WAS NO PLAN TO PERFORM REVISION SURGERY. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23276963 ↗
Other Intervertebral Fusion Device With Integrated Fixation, Cervical devices
- NA 03.617.902Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical103 reports
- NA 03.617.900Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical77 reports
- Divergence® Anterior Cervical Fusion System G6626525Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical75 reports
- Divergence® Anterior Cervical Fusion System G6626526Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical49 reports
- NA 03.617.905Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical29 reports
- NA 03.617.904Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical27 reports
- Divergence® Anterior Cervical Fusion System G6626746Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical21 reports
- NA 03.647.972Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical17 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 18, 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