CD HORIZON® Spinal System 75446550Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885074134130), received between Nov 18, 2016 and Sep 6, 2024 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 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 SPINAL THERAPY. IT WAS REPORTED THAT, THE TULIP GOT DETACHED FROM THE SHANK AFTER IMPLANTATION. PROCEDURE OR TECHNIQUE PERFORMED TRANSFORAMINAL LUMBAR INTERBODY FUSION AND THE LEVELS IMPLANTED TWO LEVELS. THE IMPLANT WAS EXPELLED WITH RE-DO SURGERY AND REPLACED WITH NEW SCREW. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154794 ↗
• MalfunctionOct 23, 2023Detachment 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 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THERAPY FOR LUMBAR SPINE DEGENERATION. IT WAS REPORTED THAT THE SCREW FELL APART. SCREW WAS INSTALLED WITH THE SCREW DRIVER AND IT FELL APART WHEN TIGHTENED, AND THE IMPLANT HEAD AND SCREW BOLT WERE SEPARATED. THERE WAS NO PATIENT SYMPTOM REPORTED. A DELAY OF LESS THAN 60 MINS IN THE PROCEDURE WAS REPORTED. THERE WAS NO REVISION SURGERY PLANNED/ OCCURRED IN THIS EVENT. THERE WAS NO FRAGMENTS LEFT IN THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985807 ↗
• InjuryAug 23, 2023Material Separation; Material Separation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OPEN REDUCTION AND INTERNAL FIXATION OF THE POSTERIOR LUMBAR SPINE TO FIX THE LUMBAR VERTEBRA 3 AND LUMBAR VERTEBRA 5 FOR AN INDICATION OF BURST FRACTURE OF THE LUMBAR 4 VERTEBRAE. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM PAIN AFTER SURGERY, AND THE X-RAY EXAMINATION REVEALED THAT THE SCREW WAS BROKEN AND THE SCREW TIP WAS SEPARATED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 AND THE FAILED SCREW WAS REMOVED AND A NEW ONE WAS IMPLANTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 17601556 ↗
• MalfunctionJul 14, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING LUMBAR 4 AND 5 FIXATION AND FUSION FOR ISTHMUS RUPTURE, LUMBAR SPONDYLOLISTHESIS. IT WAS REPORTED THAT 2 YEARS AFTER THE OPERATION, THERE WAS ABNORMAL NOISE IN THE WAIST WHEN TURNING OR STRETCHING OR FLEXING AND IT WAS FOUND THAT TWO OF THE FOUR IMPLANTED SCREWS WERE BROKEN. PATIENT HAD SORENESS AND DISCOMFORT NEAR THE IMPLANT. THE COMPLAINED PRODUCT IS STILL IN THE BODY. CONSIDERING THE INJURY FROM THE PREVIOUS OPERATION, THERE IS NO PLAN TO EXPLANT IT FOR THE TIME BEING. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Discomfort

  MAUDE report 17323905 ↗
• MalfunctionMar 12, 2021Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURING REPRESENTATIVE THAT THE PRODUCT IS LOST DURING LOGISTICS TRANSPORTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11469784 ↗
• MalfunctionOct 22, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FIXATION OF 2 LEVELS WITH 4 SCREWS AND 2 RODS. INTRA-OP, PATIENT'S BONES WERE VERY HARD AND ON IMPLANTING THE SCREWS, TULIP OF ONE OF THE SCREWS BROKE AND WAS STUCK IN THE SCREWDRIVER. THE SHAFT OF THE SCREW WAS HOWEVER LEFT IMPLANTED IN THE BONE. THE SURGEON ADDED ANOTHER SCREW IN THE NEXT PEDICLE IN ORDER TO COMPLETE THE FIXATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9217509 ↗
• MalfunctionDec 19, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANT OF PEDICULAR SCREW FOR LUMBAR ARTHRODESIS DUE TO VERTEBRAL SPINE STENOSIS AT L4-L5. INTRA-OP, WHILE THE BLOCKER IN THE SCREW WAS BEING HELD, THE TULIP OF THE SAME OPENED. NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8178102 ↗
• MalfunctionDec 18, 2018Material Deformation; Material Deformation

  PRE-OP DIAGNOSIS: VERTEBRAL SPINE STENOSIS L4-L5 PROCEDURE: LUMBAR ARTHRODESIS 1 LEVEL IT WAS REPORTED THAT INTRA-OP, THE TULIP OF THE SCREW OPENED AT THE TIME OF THE FINAL LOCKING THAT PREVENTED THE SYSTEM FROM BEING LOCKED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8173135 ↗
• MalfunctionDec 6, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION. POST-OP, THE SCREW HEAD AND THREAD 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 8140015 ↗
• MalfunctionApr 14, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT SURGERY DUE TO ISTHMUS. INTRA-OP, IT WAS FOUND THE DEVICE WAS SLIPPED AND HE HAD TO REPLACE A NEW ONE TO COMPLETE THE SURGERY SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6492828 ↗
• InjuryNov 18, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING OF ROD IN THE PEDICLE SCREWS IN 2015 IN WHICH SURGEON PLACED THREE NEW PEDICLE SCREWS OF A BIGGER DIAMETER AND FIXATED THE ROD WITH NEW NUTS. POST OP SET SCREWS WERE OUT OF THE TULIP HEAD AND ROD BROKE OUT OF THE PEDICLE SCREWS AGAIN. HENCE, A REVISION SURGERY WAS NEEDED AGAIN AND TWO SCREWS WERE EXPLANTED FROM L2 AND L3. THE ROD WAS RE-USED.

  Patient problems: No Code Available; Pain

  MAUDE report 6112009 ↗
• InjuryNov 18, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING OF ROD IN THE PEDICLE SCREWS IN 2015 IN WHICH SURGEON PLACED THREE NEW PEDICLE SCREWS OF A BIGGER DIAMETER AND FIXATED THE ROD WITH NEW NUTS. POST OP SET SCREWS WERE OUT OF THE TULIP HEAD AND ROD BROKE OUT OF THE PEDICLE SCREWS AGAIN. HENCE, A REVISION SURGERY WAS NEEDED AGAIN AND TWO SCREWS WERE EXPLANTED FROM L2 AND L3. THE ROD WAS RE-USED.

  Patient problems: No Code Available; Pain

  MAUDE report 6112008 ↗

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-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-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-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
• 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