Skip to content

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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

All Intervertebral Fusion Device With Integrated Fixation, Cervical devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page