CD HORIZON® Spinal System 869-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00721902750991), received between Jun 23, 2017 and Aug 10, 2018 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K031655); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNSPECIFIED SURGERY. POST-OP, THE PATIENT COMPLAINED OF PAIN AND IT WAS CONFIRMED THROUGH RADIOGRAPHY THAT THE ROD PARTS HAVE BEEN BROKEN AND THUS A REVISION SURGERY WAS PERFORMED TO REPLACE THE ROD. THE PATIENT WAS IN A GOOD CONDITION AFTER THE REVISION.

  Patient problems: Pain

  MAUDE report 7771786 ↗
• InjuryJan 9, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PEDICLE SUBTRACTION OSTEOTOMY(PSO) AT L3 FOR CORRECTION OF SAGITTAL BALANCE. POST-OP, THE IMPLANTED RODS BROKE DUE TO PATIENT'S FALL ON BACK BY BEING PUSHED. AS A RESULT, A REVISION SURGERY WAS PERFORMED TO COMPLETELY EXPLANT THE BROKEN RODS, TO STABILIZE PATIENT'S CONDITION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7174343 ↗
• InjuryJan 9, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PEDICLE SUBTRACTION OSTEOTOMY(PSO) AT L3 FOR CORRECTION OF SAGITTAL BALANCE. POST-OP, THE IMPLANTED RODS BROKE DUE TO PATIENT'S FALL ON BACK BY BEING PUSHED. AS A RESULT, A REVISION SURGERY WAS PERFORMED TO COMPLETELY EXPLANT THE BROKEN RODS, TO STABILIZE PATIENT'S CONDITION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7174342 ↗
• InjurySep 25, 2017Break; Break

  PRE-OP DIAGNOSIS: SCOLIOSIS PROCEDURE USED: POSTERIOR SCOLIOSIS CORRECTION IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY IN WHICH THE ROD WAS IMPLANTED. POST-OP, THE ROD WAS FOUND TO BE BROKEN ON (B)(6) 2017. PATIENT UNDERWENT CORRECTION SURGERY WHERE TWO CONNECTORS WITH ONE PARALLEL ROD WERE IMPLANTED AT THE LEVEL OF THE BROKEN ROD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6889498 ↗
• InjuryJun 23, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS:REVISION AFTER HYPERKYPHOSIS LEVEL:L1 PROCEDURE:IMPLANTING SCREWS AND RODS IT WAS REPORTED ON AN UNKNOWN DATE ROD BROKE POST-OPERATIVELY. THE PATIENT HEARD A POP SOUND WHILE BENDING. PATIENT UNDERWENT A REVISION SURGERY FOR REMOVAL.

  Patient problems: No Code Available

  MAUDE report 6662661 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031655. One submission often covers many models, so check the product and lot details in each record.

• Z-2874-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) LEGACY (TM) FAS, REF 7542535, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization an