CD HORIZON® Spinal System 7576540Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885074031132), received between Oct 18, 2017 and Sep 28, 2026 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding screws used in Transforaminal Lu mbar Interbody Fusion therapy detected in MRI. It was reported that the screws broke. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910956 ↗
• InjuryMay 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MIS FIXATION FOR TUBERCULOSIS OF SPINE. LEVELS IMPLANTED: L3 TO L5 IT WAS REPORTED THAT THE SCREW GOT SEPARATED FROM ITS TULIP. HENCE, IN THE POST-OP FOLLOW-UP X-RAYS, IT WAS FOUND THAT THE SCREW HAS DISLODGED BECAUSE OF THE BREAKING OF THE IMPLANT. THE DEVICE WAS EXPLANTED. PATIENT EXPERIENCED RECURRENCE OF PAIN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 19275983 ↗
• InjuryApr 4, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS 1ST DIAGNOSIS: SPONDYLOLISTHESIS IN L5-S1. 2ND DIAGNOSIS: SPONDYLODISCITIS IN L5-S1. 3RD DIAGNOSIS: IMPLANT FAILURE OF L5-S1. FIRST SURGERY WAS MAST TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). SECOND SURGERY WAS OPEN SURGERY OF LUMBAR REGION (RE-EXPLORATION OF LUMBAR SPINE AND DEBRIDEMENT AND BONE GRAFTING). THIRD SURGERY TYPE WAS OPEN SURGERY OF LUMBAR REGION (REVISION FIXATION). LEVELS IMPLANTED: IN FIRST AND SECOND SURGERY SINGLE LEVEL IMPLANTED. HOWEVER, IN THIRD SURGERY DOUBLE LEVELS IMPLANTED. IT WAS REPORTED THAT THE SCREWS WERE BROKEN. ON FOLLOW UP AFTER 1 AND HALF MONTH OF FIRST SURGERY (MAST TLIF), PATIENT WAS DIAGNOSED WITH SPONDYLODISCITIS. THEREFORE SECOND SURGERY WAS PERFORMED. PATIENT HAD SEVERE LOWER BACK PAIN. THERE WERE NO OTHER PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 19039475 ↗
• InjuryFeb 23, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MIS TLIF. IT WAS REPORTED THAT THE PATIENT HAD PAIN IN THE SURGICAL SITE AND UNDERWENT IMPLANT REMOVAL SURGERY (B)(6) 2024. HOWEVER DURING THE SURGERY, IT WAS DISCOVERED THAT THE SCREW IN THE S1 HAD ALREADY BROKEN, AND ONLY HALF OF IT REMAINED ON THE S1 BODY. PATIENT'S FIRST SURGERY WAS ON LAST (B)(6) 2021 FOR TLIF 2 LEVEL AND HE DEVELOPED AN INFECTION ON THE SURGICAL SITE ALMOST A YEAR LATER. AS A RESULT, HIS SECOND SURGERY WAS PERFORMED LAST (B)(6) 2022 TO REMOVE ALL THE SCREWS ON THE LEFT SIDE AND NO ADDITIONAL IMPLANTS WERE PLACED. THE MOST RECENT SURGERY WAS PERFORMED ON (B)(6) 2024, WHERE THE REMAINING THREE SCREWS ON THE RIGHT L4-L5-S1 WERE REMOVED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 18765429 ↗
• InjuryJan 25, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN L 4-L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY. IT WAS REPORTED THAT THE SCREW WAS BROKEN AND NO FRAGMENTS LEFT INSIDE THE PATIENT. AN ADDITIONAL SURGERY WAS PERFORMED TO REPLACE THE TOTAL CONSTRUCT WITH NEW SCREWS. THE PATIENT HAD PAIN AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 18578622 ↗
• InjuryJul 29, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST AN L1 -L3 PERCUTANEOUS MIS PROCEDURE IN A PATIENT DIAGNOSED WITH L2 BURST FRACTURE. IT WAS REPORTED THAT AFTER THE SURGERY DURING FOLLOW UP WITH THE PATIENT, IMPLANT BREAKAGE WAS NOTICED. REVISION SURGERY WAS PERFORMED TO EXPLANT THE BROKEN SCREWS AND STABILIZE THE L1 - L3 AGAIN. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127848 ↗
• InjuryJul 29, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST AN L1 -L3 PERCUTANEOUS MIS PROCEDURE IN A PATIENT DIAGNOSED WITH L2 BURST FRACTURE. IT WAS REPORTED THAT AFTER THE SURGERY DURING FOLLOW UP WITH THE PATIENT, IMPLANT BREAKAGE WAS NOTICED. REVISION SURGERY WAS PERFORMED TO EXPLANT THE BROKEN SCREWS AND STABILIZE THE L1 - L3 AGAIN. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127843 ↗
• MalfunctionMar 4, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MISTLIF SPINAL THERAPY. IT WAS REPORTED THAT THE LEGACY SCREW TULIP HEAD HAD BEEN SEPARATED FROM SCREW BODY. WHILE IMPLANTING THE PRODUCT TO PATIENT BODY THE SURGEON FOUND SOME DISCREPANCY ON CHECKING AT C ARM IMAGES. THE DAMAGED SCREW WAS IMMEDIATELY EXPLANTED FROM PATIENT BODY. AND ANOTHER SCREW WAS PLACED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ALLERGIES: NOT KNOWN CHIEF COMPLAINTS AND DURATION: LOWER BACK PAIN RADIATING TO B/L LOWER LIMB (L>R) FOR LAST 5-6 MONTHS. HISTORY OF PRESENTING ILLNESS: (B)(6), FEMALE, KLCLO HTN, DYSLIPIDEMIA, PRESENTED WITH LOWER BACK PAIN RADIATING TO B/L LOWER LIMB (L>R) FOR LAST 5-6 MONTHS WHICH ARE PROGRESSIVE IN NATURE. NO H/O FALL, TRAUMA, LOC, CONVULSION, NAUSEA, VOMITING, CHEST PAIN LIMB WEAKNESS. BOWEL AND BLADDER HABITS ARE NORMAL . MRI REVEALED L4-L5 LISTHESIS. PAST MEDICAL HISTORY: KLCLO HTN, DYSLIPIDEMIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13665929 ↗
• MalfunctionFeb 2, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE AND DISTRIBUTOR REGARDING A PATIENT IMPLANTED WITH A SCREW IN AN UNKNOWN SPINAL THERAPY FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE SCREW BROKE DURING SURGERY AND THERE WAS A FRAGMENT REMAINING IN THE PATIENT'S BODY. THERE WAS NO PATIENT INJURY AS A RESULT OF THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13421472 ↗
• InjuryFeb 15, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MINIMALLY INVASIVE PROCEDURE. POST-OP, THE SCREW BROKE AND PERSISTENT INFECTION IN DISC SPACE L4/L5 AND L5/S1 WAS OBSERVED. SO A REVISION SURGERY WAS PERFORMED TO EXPLANT THE SCREW. NO FRAGMENTS OF THE BROKEN PART REMAINS INSIDE THE PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 7272522 ↗
• InjuryOct 18, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: NERVE COMPRESSION 1 YEAR AFTER SPONDYLODESE LEVELS IMPLANTED: L5-S1 IT WAS REPORTED THAT POST-OP, AFTER ONE YEAR, CANNULATED SCREW BROKE AT S1. THE PATIENT HAD NO COMPLAINTS AFTER 10 MONTHS, BUT SUDDENLY THERE WERE SOME IRRADIATION TO THE RIGHT LEG. PATIENT SUFFERED FROM NERVE COMPRESSION. AFTER ONE YEAR THERE WAS NOT ENOUGH FUSION BETWEEN L5-S1. THE SCREW WAS TAKEN OUT DURING REVISION SURGERY AND THE SURGEON PLACED NEW SCREW AT S1.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6957247 ↗
• InjuryOct 18, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: NERVE COMPRESSION 1 YEAR AFTER SPONDYLODESE LEVELS IMPLANTED: L5-S1 IT WAS REPORTED THAT POST-OP, AFTER ONE YEAR, CANNULATED SCREW BROKE AT S1. THE PATIENT HAD NO COMPLAINTS AFTER 10 MONTHS, BUT SUDDENLY THERE WERE SOME IRRADIATION TO THE RIGHT LEG. PATIENT SUFFERED FROM NERVE COMPRESSION. AFTER ONE YEAR THERE WAS NOT ENOUGH FUSION BETWEEN L5-S1. THE SCREW WAS TAKEN OUT DURING REVISION SURGERY AND THE SURGEON PLACED NEW SCREW AT S1.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 6957246 ↗