C-CURVE B20520015Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03613720275688), received between Jun 5, 2026 and Jun 8, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) PROCEDURE. IT WAS REPORTED THAT THE SCREW WAS BROKEN. NO FRAGMENTS OF THE IMPLANT OR INSTRUMENT REMAINED IN THE PATIENT. THE PRODUCT WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE SCREW BREAK HAPPENED DURING IMPLANTATION ITSELF AND THE PRODUCT EXPLANTED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25432123 ↗
• MalfunctionJun 8, 2026Break; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A C5-C6 DECOMPRESSION AND FUSION PROCEDURE, ONE OF THE SCREWS BROKE INTRA-OPERATIVELY AND ENDED UP IN THE DISC SPACE. THIS REQUIRED ADDITIONAL PROCEDURE TIME TO REMOVE THE BROKEN SCREW AND REPLACE ALL IMPLANTS WITH NEW ONES. THE PROCEDURE INVOLVED NOT USING THE INSERTER AS A GUIDE FOR DRILLING THE SCREW HOLES, CONTRARY TO OFFICIAL RECOMMENDATIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430982 ↗
• MalfunctionJun 8, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE FIRST SCREW - THREAD INSIDE SCREW (IN SLOT WHERE SCREWDRIVER INSERTS) THREAD CAME OFF IN LITTLE METAL PIECES AND WAS UNABLE TO ADVANCE SCREW ANY FURTHER AND ALSO UNABLE TO REMOVE SCREW (SCREW AND CAGE AS IT WAS NOW FIXED INSIDE). THE SECOND SCREW ON SECOND LEVEL, THE SCREW HEAD BROKE OFF WITH THE THREADED SHAFT IN PATIENT AND HEAD PART BROKE OFF DURING IMPLANTATION. SURGEON WAS ABLE TO REMOVE HEAD PART AND WAS UNABLE TO ADVANCE SCREW ANY FURTHER AND ALSO UNABLE TO REMOVE SCREW (SCREW AND CAGE AS IT WAS NOW FIXED INSIDE). CAGES IN PLACE BUT NOT AS FULL SEATED AS SURGEON WOULD PREFER. THERE WAS NO CONFIRMED PLAN FOR A REVISION SURGERY TO EXPLANT THE BROKEN SCREWS. THE PROCEDURE PERFORMED WAS A ANTERIOR CERVICAL DISCECTOMY AND FUSION. THE IMPLANTS WERE PLACED IN LEVELS C5¿C6 AND C6-C7. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25424384 ↗
• MalfunctionJun 5, 2026Break; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A C5-C6 DECOMPRESSION AND FUSION PROCEDURE, ONE OF THE SCREWS BROKE INTRA-OPERATIVELY AND ENDED UP IN THE DISC SPACE. THIS REQUIRED ADDITIONAL PROCEDURE TIME TO REMOVE THE BROKEN SCREW AND REPLACE ALL IMPLANTS WITH NEW ONES. THE PROCEDURE INVOLVED NOT USING THE INSERTER AS A GUIDE FOR DRILLING THE SCREW HOLES, CONTRARY TO OFFICIAL RECOMMENDATIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414028 ↗
• MalfunctionJun 5, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE FIRST SCREW - THREAD INSIDE SCREW (IN SLOT WHERE SCREWDRIVER INSERTS) THREAD CAME OFF IN LITTLE METAL PIECES AND WAS UNABLE TO ADVANCE SCREW ANY FURTHER AND ALSO UNABLE TO REMOVE SCREW (SCREW AND CAGE AS IT WAS NOW FIXED INSIDE). THE SECOND SCREW ON SECOND LEVEL, THE SCREW HEAD BROKE OFF WITH THE THREADED SHAFT IN PATIENT AND HEAD PART BROKE OFF DURING IMPLANTATION. SURGEON WAS ABLE TO REMOVE HEAD PART AND WAS UNABLE TO ADVANCE SCREW ANY FURTHER AND ALSO UNABLE TO REMOVE SCREW (SCREW AND CAGE AS IT WAS NOW FIXED INSIDE). CAGES IN PLACE BUT NOT AS FULL SEATED AS SURGEON WOULD PREFER. THERE WAS NO CONFIRMED PLAN FOR A REVISION SURGERY TO EXPLANT THE BROKEN SCREWS. THE PROCEDURE PERFORMED WAS A ANTERIOR CERVICAL DISCECTOMY AND FUSION. THE IMPLANTS WERE PLACED IN LEVELS C5¿C6 AND C6-C7. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25413756 ↗
• MalfunctionJun 5, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS NON-SPECIFIC NEURAL COMPRESSION (NSNC). IT WAS REPORTED THAT, THIS WAS A REVISION OF A FAILED SURGERY. TO PERFORM THE PROCEDURE ANTERIOR CERVICAL DISCECTOMY AND FUSION, SURGEON HAD TO REMOVE THE TWO PREVIOUS C-CURVE IMPLANTS, CARRY OUT A DOUBLE CORPECTOMY, AND IMPLANT A MOS MESH. IT WAS IDENTIFIED THAT THERE WAS A PROBLEM WITH THE C-CURVE SCREW DURING THE REMOVAL OF THE IMPLANT. LEVELS IMPLANTED DURING INITIAL SURGERY WAS C3-C4 AND C6-C7. THERE WAS NO FRAGMENT OF BROKEN SCREWS LEFT INSIDE PATIENT BODY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED STATING A WEEK AFTER THE FIRST INTERVENTION, THE PATIENT STILL COMPLAINED OF MYELOPATHY. THE FIRST SURGERY DID NOT SOLVE THE PATIENT'S PATHOLOGY. THE MAIN CAUSE OF THE NON-FUSION WAS TIME. ONLY 1 MONTH HAS PASSED BETWEEN THE FIRST AND THE SECOND INTERVENTION. THEREFORE, THE REASON FOR REOPERATION WAS MAINLY A PROBLEM WITH THE INDICATION AND SURGERY, NOT WITH THE IMPLANTED MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25412539 ↗