CD HORIZON® Spinal System 5442136Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994588456), received between Dec 19, 2018 and Nov 18, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T11-L3 POSTERIOR SPINAL FUSION DUE TO TRAUMA MVA, L1 FRACTURE. IT WAS REPORTED THAT MIDDLE BOLT OF CROSSLINK "STRIPPED OUT" AND DID NOT TORQUE/FINAL TIGHTEN. UPON TRYING TO REPLACE CROSSLINK, THE SURGEON ATTEMPTED TO UNLOCK THE GOLD SET SCREWS WHICH HAD ALREADY BEEN FINAL TIGHTENED; HOWEVER, ONE OF THESE STRIPPED DURING THE REMOVAL PROCESS AS WELL. THE SURGEON WAS THEN UNABLE TO GET THIS PIECE OF THE GOLD SET SCREW UNLOCKED OFF THE ROD; THEREFORE, HE CHOSE TO DRILL OUT THE CROSSLINK AT THE LOCATION NEAR THE SET SCREW IN ORDER TO REMOVE THE CROSSLINK SO THAT IT COULD BE REPLACED WITH A NEW CROSSLINK. SURGEON CLEANED OUT THE THE WOUND WITH PULSED LAVAGE USING NORMAL SALINE WITH ANTIBIOTIC.  THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834153 ↗
• MalfunctionJul 1, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THORACOLUMBAR/LUMBAR SPINE SURGERY DUE TO BURST FRACTURE OF THE LUMBAR 4 VERTEBRAL BODY. INTRA-OP, WHILE USING CROSSLINK FOR BREAKING SCREW PLUG, THE LOWER SIDE OF ONE SIDE OF THE SCREW PLUG BROKE AT THE THREADED JOINT. IT WAS REMOVED INTRA-OPERATIVELY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10216731 ↗
• MalfunctionApr 24, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CERVICAL SPONDYLOTIC MYELOPATHY; AND UNDERWENT POSTERIOR CERVICAL DECOMPRESSION AND FUSION. INTRA-OP, THE IMPLANT BROKE. HENCE, THE BROKEN PRODUCT WAS EXPLANTED COMPLETELY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9994559 ↗
• MalfunctionSep 27, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FUSION AT T1-T6 DUE TO OSTEOMYELITIS. INTRA-OP, DURING FINAL TIGHTENING THE MIDDLE NUT OF HE CROSSLINK, A PIECE OF THE MIDDLE NUT SHEARED OFF. THE SHEARED PART OF THE CROSSLINK WAS EXPLANTED WHILE THE REMAINING PART OF CROSSLINK REMAINS IMPLANTED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9131609 ↗
• MalfunctionMar 12, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH T5 FRACTURE AND UNDERWENT POSTERIOR FUSION FROM T2 TO T7 LEVELS. DURING SURGERY, THE TOP OF THE CROSSLINK SET SCREW SHEARED OFF. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE FRAGMENT OF THE SET SCREW STILL REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8411201 ↗
• MalfunctionDec 19, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THORACIC FUSION SURGERY AT T1-T7 DUE TO THORACIC BURST FRACTURE. INTRA-OP, THE SURGEON HAD PLACED THE CROSSLINKS, BUT AFTER HE HAD BROKEN OFF THE OUTER SET SCREWS, HE WAS NOT HAPPY WITH THE PLACEMENT OF THE CROSSLINKS. HE ATTEMPTED TO REMOVE THE CROSSLINKS, BUT THE SET SCREWS OF THE CROSSLINKS STRIPPED. AS HE WAS NOT ABLE TO REMOVE THE CROSSLINKS, HE TOOK OUT THE RODS WITH THE CROSSLINKS ATTACHED TO THE THEM. HE THEN PLACED THE NEW RODS. NO FRAGMENT OF THE STRIPPED CROSSLINK REMAINED INSIDE THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8177835 ↗

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