CD HORIZON® Growth Rod Conversion Set 7340000GRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20643169549771), received between Jan 3, 2025 and Apr 22, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 22, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR GROWING ROD EXTENSION TECHNIQUE. PROCEDURE OR THERAPY PERFORMED WAS EXTENSION SURGERY FOR THE GROWING ROD. IT WAS REPORTED THAT THE SET SCREW BROKE BEFORE THE BREAK-OFF. DURING GROWING ROD EXTENSION, THE DISTRACTOR CAME OFF AND INTERFERED WITH THE SET SCREW. IT IS BELIEVED THAT THE BREAKAGE WAS CAUSED BY THIS IMPACT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THIS SURGERY IS A REPEAT SURGERY. DEVICE HAS BEEN EXPLANTED-PARTIALLY. PRODUCT WAS IMPLANTED AND EXPLANTED ON THE SAME DAY, (B)(6) 2023. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT BODY, SO NO PLAN FOR ADDITIONAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879143 ↗
• MalfunctionApr 22, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR GROWING ROD EXTENSION TECHNIQUE. PROCEDURE OR THERAPY PERFORMED WAS EXTENSION SURGERY FOR THE GROWING ROD. IT WAS REPORTED THAT THE SET SCREW BROKE BEFORE THE BREAK-OFF. DURING GROWING ROD EXTENSION, THE DISTRACTOR CAME OFF AND INTERFERED WITH THE SET SCREW. IT IS BELIEVED THAT THE BREAKAGE WAS CAUSED BY THIS IMPACT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THIS SURGERY IS A REPEAT SURGERY. DEVICE HAS BEEN EXPLANTED-PARTIALLY. PRODUCT WAS IMPLANTED AND EXPLANTED ON THE SAME DAY, (B)(6) 2023. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT BODY, SO NO PLAN FOR ADDITIONAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879138 ↗
• MalfunctionApr 22, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR GROWING ROD EXTENSION TECHNIQUE. PROCEDURE OR THERAPY PERFORMED WAS EXTENSION SURGERY FOR THE GROWING ROD. IT WAS REPORTED THAT THE SET SCREW BROKE BEFORE THE BREAK-OFF. DURING GROWING ROD EXTENSION, THE DISTRACTOR CAME OFF AND INTERFERED WITH THE SET SCREW. IT IS BELIEVED THAT THE BREAKAGE WAS CAUSED BY THIS IMPACT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THIS SURGERY IS A REPEAT SURGERY. DEVICE HAS BEEN EXPLANTED-PARTIALLY. PRODUCT WAS IMPLANTED AND EXPLANTED ON THE SAME DAY, (B)(6) 2023. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT BODY, SO NO PLAN FOR ADDITIONAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879126 ↗
• MalfunctionMar 28, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THEY REMOVED FRAGMENTS OF THE SET SCREW AFTER FINAL TIGHTENING. FRAGMENTS OF THE PRODUCT FELL TO THE PLEURA LEVEL, RAISING SUSPICIONS OF COMPLICATIONS INVOLVING THE LUNG. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE TYPE OF PROCEDURE/THERAPY INVOLVED DURING THE EVENT WAS GLOW INGROD METHOD FOR CHILDHOOD SCOLIOSIS. REOPERATION DUE TO ONE-SIDED ROD BREAKAGE. ROD IMPLANTING DATE: (B)(6) 2024. THE DAMAGED ROD WAS REMOVED AND A NEW ROD WAS INSTALLED. THE ACTUAL PRODUCT HAS BEEN DISCARDED AND COULD NOT BE RETURNED. A THREADED PIECE OF THE SET SCREW FELL OUT INTO THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718519 ↗
• MalfunctionJan 5, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAG NOSIS FOR GROWING ROD EXTENSION TECHNIQUE. PROCEDURE OR THERAPY PERFORMED WAS EXTENSION SURGERY FOR THE GROWING ROD. IT WAS REPORTED THAT THE SET SCREW BROKE BEFORE THE BREAK-OFF. DURING GROWING ROD EXTENSION, THE DISTRACTOR CAME OFF AND INTERFERED WITH THE SET SC REW. IT IS BELIEVED THAT THE BREAKAGE WAS CAUSED BY THIS IMPACT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THIS SURGERY IS A REPEAT SURGERY. DEVICE HAS BEEN EXPLANTED-PARTIALLY. PRODUCT WAS IMPLANTED AND EXPLANTED ON THE SAME DAY, (B)(6) 2023. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT BODY, SO NO PLAN FOR ADDITIONAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076053 ↗
• MalfunctionJan 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR GROWING ROD EXTENSION TECHNIQUE. PROCEDURE OR THERAPY PERFORMED WAS EXTENSION SURGERY FOR THE GROWING ROD. IT WAS REPORTED THAT THE SET SCREW BROKE BEFORE THE BREAK-OFF. DURING GROWING ROD EXTENSION, THE DISTRACTOR CAME OFF AND INTERFERED WITH THE SET SCREW. IT IS BELIEVED THAT THE BREAKAGE WAS CAUSED BY THIS IMPACT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THIS SURGERY IS A REPEAT SURGERY. DEVICE HAS BEEN EXPLANTED-PARTIALLY. PRODUCT WAS IMPLANTED AND EXPLANTED ON THE SAME DAY, (B)(6) 2023. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT BODY, SO NO PLAN FOR ADDITIONAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067994 ↗