Skip to content

C-CURVE A20501600Recalls & reported problems

Medicrea International · C-CURVE SQUARED AWL · Class 1

Data updated Oct 16, 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 03613720283621), received between Jan 3, 2023 and Jan 3, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 3, 2023Break; Break

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE END SUCTION OF THE SQUARE TIP BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS LEFT INSIDE THE PATIENT AND AN ADDITIONAL SURGERY WAS PERFORMED TO REMOVE THE DEVICE FRAGMENTS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 16087823 ↗

Other Awl devices

All Awl devices →

Sources and updates

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