CD HORIZON® Spinal System 75446545Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00885074134123), received between Feb 3, 2017 and Oct 23, 2024 — classified as 7 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

4 other recalls cover devices cleared under the same FDA submission (K042025); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 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 L3-L4 TLIF WITH L3-S1 PSF + L3-S1 LAMINECTOMY FOR L3-L4 SPONDYLOLISTHESIS + L3-S1 CENTRAL STENOSIS. IT WAS REPORTED THAT THE SCREW WAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE SHAFT OF THE SCREW WAS DISLODGED FROM THE TULIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513845 ↗
• MalfunctionMay 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE PEDICLE SCREW GOT DISENGAGED FROM THE SCREW SHAFT BEFORE USING IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339101 ↗
• MalfunctionApr 23, 2024Material Separation; Material Separation

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE L4-S1 TLIF PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE L5 SCREW TULIP DISENGAGED FROM SHAFT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19162192 ↗
• InjuryApr 2, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN R EVISION SURGERY. LEVELS IMPLANTED WAS S1-L5. IT WAS REPORTED THAT THE HEADS OF TWO PEDICLE SCREWS WERE POPPED OUT AND BROKEN DURING REVISION SURGERY. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT REASON FOR REVISION SURGERY WAS THAT TWO SCREWS WERE NOT PROPERLY ALIGNED OR POSITIONED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE INITIAL SURGERY WAS DONE IN 2022 AND THE MDT LEGACY SCREWS WERE IMPLANTED. THIS YEAR (B)(6) 2024 PATIENT WENT TO ANOTHER SURGEON FOR SECOND OPINION. SURGEON SUGGESTED REVISION OF TWO SCREWS WHICH WERE NOT ALIGNED OR IN GOOD POSITION. DURING REVISION SURGERY HE REMOVED THE TWO SCREWS AND REPLACED THEM. WHILE IN THE PROCESS OF REMOVING DURING INTRA-OP THE TWO SCREW HEADS POPPED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19017679 ↗
• MalfunctionMar 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A MUL TI-AXIAL SCREW HAVING L4-L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THERAPY FOR L4-L5 SPONDYLOLISTHESIS WITH CENTRAL STENOSIS. IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE. TULIP AND THE SCREW WERE DETACHED DURING SURGERY. THERE WAS NO REVISION SURGERY PLANNED/ OCCURRED AS A RESULT OF THE EVENT. 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 18814762 ↗
• InjuryFeb 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED IN THORACOLUMBAR POSTERIOR OPEN SURGERY. IT WAS REPORTED THAT THE SCREW SHANK AND SCREW TIP DETACHED INSIDE THE PATIENT. THE DEVICE WAS IMPLANTED IN THE BODY FOR FOUR DAYS, AND THE FRACTURE WAS NOT FUSED. INSTEAD OF A FRACTURE, THE IMAGING SHOWED THAT THE SCREW ROD HAD DISLODGED FROM THE SCREW TIP JUNCTION. DUE TO THE PATIENT'S INFECTION WITH THE COVID-19, THE ATTENDING PHYSICIAN BELIEVED THAT IT WAS NOT SUITABLE FOR A SECOND OPERATION TO REMOVE THE IMPLANT, AND PLANNED TO PERFORM AN ADDITIONAL OPERATION TO REMOVE THE IMPLANT IN THREE MONTHS. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292789 ↗
• MalfunctionApr 1, 2021Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED IN LUMBAR DISCECTOMY WITH SPINAL CANAL DECOMPRESSION, FUSION AND INTERNAL FIXATION. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS LUMBAR SPINAL STENOSIS, LUMBAR DISC HERNIATION, LUMBAR SPONDYLOLISTHESIS, TYPE 2 DIABETES. IT WAS REPORTED THAT THE SCREW TIP IS BROKEN AND FELL OFF, NO FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT. DURING THE SURGICAL SCREW IMPLANTATION PROCESS, THE SCREW TIP FELL OFF WHEN THE SCREW WAS SCREWED IN, AND THE AGENT IMMEDIATELY REPLACED A NEW SCREW TO CONTINUE THE IMPLANTATION NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A DELAY OF LESS THAN 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600684 ↗
• MalfunctionJul 24, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR SPONDYLOLISTHESIS REDUCTION. INTRA-OP, THE SCREW BROKE. THE BROKEN SCREW WAS REPLACED WITH A NEW ONE. NO FRAGMENT OF THE BROKEN SCREW REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8821229 ↗
• MalfunctionMay 22, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REDUCTION OF LUMBAR SPONDYLOLISTHESIS DUE TO LUMBAR SPONDYLOLISTHESIS. INTRA-OP, THE SCREW BROKE. THE SCREW WAS REPLACED WITH THE NEW ONE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8631161 ↗
• InjuryMar 29, 2019Break; Break

  PROCEDURE USED: ARTHRODESIS LUMBAR LEVELS: L4-L5 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE SCREWS BROKE. PATIENT REPORTED BACK PAIN DUE TO THE EVENT. THE SCREWS WERE EXPLANTED IN THE REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 8463395 ↗
• InjuryMar 29, 2019Break; Break

  PROCEDURE USED: ARTHRODESIS LUMBAR LEVELS: L4-L5 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE SCREWS BROKE. PATIENT REPORTED BACK PAIN DUE TO THE EVENT. THE SCREWS WERE EXPLANTED IN THE REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 8463394 ↗
• MalfunctionFeb 20, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH INTERVERTEBRAL DISC HERNIATION AND UNDERWENT DECOMPRESSION INTERNAL FIXATION OF L5-S1. DURING THE SURGERY, SCREW WAS BENT TO THE PROXIMAL END OF THE SCREWDRIVER AND WAS BROKEN. IT COULD NOT BE REMOVED IN THE TIP OF SCREW, WHICH CAUSED THE SCREW TO BE SCRAPPED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8353352 ↗
• MalfunctionJun 6, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L4-S1 POSTERIOR LUMBAR INTERBODY FUSION DUE TO SOME UNKNOWN REASONS. INTRA-OP, THE HEAD OF THE SCREW IMPLANTED AT S1 SPLAYED, AND WOULD NOT HOLD A SET SCREW. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7572709 ↗
• MalfunctionMay 25, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION. POST-OP, THE SCREW HEAD AND TH READ WAS FOUND SEPARATED AND BROKEN. THE PRODUCT CAME IN CONTACT WITH PATIENT. NO FRAGMENTS OF THE BROKEN PART REMAINS IN THE PATIENT. PATIENT COMPLICATIONS WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7546507 ↗
• InjuryApr 13, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A SCREW. POST-OP, THE SCREW BROKE. THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF THE SCREW. NO FRAGMENTS OF THE SCREW REMAINED INSIDE THE PATIENT. THE PATIENT HAD NOT ACHIEVED SOLID FUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7430502 ↗
• MalfunctionFeb 9, 2018Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED: MINIMALLY INVASIVE SPINAL FUSION NO ADDITIONAL/REVISION SURGERY HAS BEEN PERFORMED TO EXPLANT THE PRODUCT. PATIENT CONDITION IS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7258526 ↗
• MalfunctionDec 19, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT HAD LUMBAR FRACTURE DUE TO WHICH PATIENT HAD TO UNDERGO LUMBAR FRACTURE REPAIR. DURING SURGERY, THE SCREW WAS FOUND SLIPPED. IT WAS EXPLANTED COMPLETELY FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7127998 ↗
• InjurySep 13, 2017Break; Break

  IT WAS REPORTED THAT POST-OP, THE SCREW WAS FRACTURED. PATIENT UNDERWENT REVISION SURGERY AND THE SCREW WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6860868 ↗
• MalfunctionAug 22, 2017Break; Break

  PRE-OP DIAGNOSIS: L5-S1 DEGENERATION PROBLEM PROCEDURE USED: POSTERIOR LUMBAR INTERBODY FUSION IT WAS REPORTED THAT DURING SURGERY, A SCREW BROKE AT THE MULTI-AXIAL FRAGMENT. THE SCREW CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6809457 ↗
• MalfunctionAug 1, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGERY ON AN UNKNOWN DATE IN WHICH SCREW WAS IMPLANTED. POST OP THE SPONDYLOSIS WAS OBSERVED BECAUSE OF WHICH THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2017. DURING REVISION SURGERY, AFTER THE RELEASE OF THE SET SCREWS THE SURGEON WANTED TO GIVE SOME DISTRACTION BETWEEN THE 2 SCREWS. ONE OF THE SCREWS BROKE HALFWAY, SO THAT SCREW WAS EXPLANTED. THE ROD WAS IN PLACE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6756241 ↗
• InjuryFeb 3, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON: (B)(6) 2009: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: KYPHOSIS ACQUIRED. OSTEOPOROSIS. HISTORY OF CRANIOPHARYNGIOMA. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: POSTERIOR SPINAL FUSION WITH SEGMENTAL INSTRUMENTATION T2 THROUGH T10. IMAGE-GUIDED SURGERY. SMITH-PETERSEN OSTEOTOMIES, T6-7 AND T7-8. T5 VERTEBRAL COLUMN RESECTION. INSERTION OF STRUCTURAL INTERVERTEBRAL DEVICE. APPLICATION GARDNER-WELLS TONGS. PATIENT IS WITH A HISTORY OF A T5 FRACTURE AND A MARKED PROGRESSIVE SYMPTOMATIC KYPHOTIC DEFORMITY. PER OP NOTES, T5 DISK SPACE WAS IDENTIFIED. INITIALLY, A 13 X 30 MM HIGH MESH CAGE WAS SELECTED AND THIS HAD TO BE TRIMMED BACK ABOUT 8-9 MM. THIS WAS THEN FILLED WITH LOCAL BONE AND A RHBMP-2/ACS. THIS WAS THEN SEATED INTO PLACE AT THAT T5 DEFECT LEVEL. THIS WAS DONE FROM THE RIGHT SIDE. THE LOCAL BONE PLUS 60 ML OF ALLOGRAFT BONE ALONG WITH THE REMAINING 5 SPONGES FROM THE LARGE BMP KIT WERE USED TO PERFORM THE POSTERIOR FUSION. AT T10, 6.5 X 45 MM SCREWS WERE PLACED BILATERALLY PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2009: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: KYPHOSIS ACQUIRED

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 6299479 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042025. One submission often covers many models, so check the product and lot details in each record.

• Z-0464-2012 · Nov 30, 2011 · Terminated
  CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic Sofamor Danek USA, 1800
• Z-0465-2012 · Nov 30, 2011 · Terminated
  CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Py
• Z-2875-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization a
• Z-2878-2011 · Jun 28, 2011 · Terminated
  ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilizat