CD HORIZON® Spinal System 54840016540Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994592385), received between Nov 14, 2017 and May 3, 2022 — classified as 4 injuries, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K091974); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A MEDTRONIC LEGAL REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW IN AN UNKNOWN SPINAL THERAPY FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE PATIENT SUSTAINED INJURIES FROM A BROKEN SCREW IN HER BACK. THERE WAS NO FURTHER INFORMATION PROVIDED. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Spinal Column Injury

  MAUDE report 14268194 ↗
• InjuryApr 27, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPONDYLOLISTHESIS; AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-L5 BILATERALLY. THEN, THE PATIENT FRACTURED HER VERTEBRAL BODY. SO, THE RIGHT L5 SCREW WAS REMOVED AND SCREWS WERE PLACED AT S1 BILATERALLY. L4-S1 LEVELS WERE FIXATED IN THIS SURGERY. 7-10 DAYS POST-OP, THE BILATERAL S1 SCREWS FRACTURED. THE PATIENT ALSO SUFFERED FROM RIGHT SIDE PAIN DUE TO THE BROKEN SCREWS. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE BROKEN SCREWS WERE REMOVED AND WERE REPLACED WITH NEW SCREWS.

  Patient problems: Pain

  MAUDE report 10001754 ↗
• InjuryApr 27, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SPONDYLOLISTHESIS; AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-L5 BILATERALLY. THEN, THE PATIENT FRACTURED HER VERTEBRAL BODY. SO, THE RIGHT L5 SCREW WAS REMOVED AND SCREWS WERE PLACED AT S1 BILATERALLY. L4-S1 LEVELS WERE FIXATED IN THIS SURGERY. 7-10 DAYS POST-OP, THE BILATERAL S1 SCREWS FRACTURED. THE PATIENT ALSO SUFFERED FROM RIGHT SIDE PAIN DUE TO THE BROKEN SCREWS. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE BROKEN SCREWS WERE REMOVED AND WERE REPLACED WITH NEW SCREWS.

  Patient problems: Pain

  MAUDE report 10001726 ↗
• InjuryOct 1, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH NON-FUSION AND UNDERWENT SEMI OPEN, POSTERIOR APPROACH FUSION SURGERY AT L5-S1 LEVELS. INTRA-OPERATIVELY, IT WAS DISCOVERED THAT THE IMPLANTED SCREW HAD BROKEN AND WAS STILL EMBEDDED IN THE PATIENT'S PEDICLE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7921560 ↗
• InjuryNov 14, 2017Break; Break

  IT WAS REPORTED THAT ON: (B)(6)2013:PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF DISKOGENIC PAIN WITH DEGENERATIVE DISK DISEASE, LUMBAR PAIN, L4-5, L5-S1. PROCEDURE PERFORMED: 1. ANTERIOR LUMBAR INTERBODY FUSION, L4-5, L5-S1 2. IMPLANTATION OF BONE SPACER, L4-5, L5-S1 3. ANTERIOR PLATING, L4-5, L5-S1 4. ANTERIOR DISKECTOMY, L4-5, L5-S1 AS PER OP NOTES: THE ANTERIOR LONGITUDINAL LIGAMENT AND ANNULUS WERE INCISED AND DISKECTOMIES PERFORMED AT L4-5 AND L5-S1, ALL THE WAY BACK TO THE POSTERIOR LONGITUDINAL LIGAMENT. BOTH WERE SIXED TO A 15 MM AND 15 MM SPACERS WERE SELECTED AFTER BEING PACKED WITH BONE MATRIX. THE IMPLANTS WERE THEN PUT IN PLACE AT L4-5, L5-S1 LEVEL. THEN, AT THE L5-S1 LEVEL A 3 HOLE PLATE WAS ATTACHED USING THREE 25 MM SCREWS AND WAS LOCKED INTO POSITION. AT THE L4-L5 LEVEL A 4-HOLE PLATE WAS ATTACHED USING FOUR SCREWS AND ONE 30 MM SCREW. LATERAL FLUOROSCOPY SHOWED GOOD POSITION. WOUND WAS CLOSED. (B)(6)2013: PATIENT UNDERWENT THE FOLLOWING PROCEDURES: 1. POSTERIOR PERCUTANEOUS FUSION AT L4-L5, L5-S1 WITH FACET FUSION RIGHT L4-L5. L5-S1 2. PERCUTANEOUS SCREW PLACEMENT L4,S1 3. ALLOGRAFT GRAFTING AS PER OP NOTES: ¿ PATIENT WAS TAKEN TO THE OPERATING ROOM, WHERE AFTER

  Patient problems: Depression; Discomfort; Injury; Numbness; Pain

  MAUDE report 7030883 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091974. One submission often covers many models, so check the product and lot details in each record.

• Z-2876-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilizatio