CD HORIZON® Spinal System 5442141Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994579539), received between Mar 17, 2017 and Sep 15, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2022Break; Break

  INFORMATION RECEIVED FROM REGULATORY BODY VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCT. IT WAS REPORTED THAT, THE TIP OF SCREW THAT HOLDS THE IMPLANT IN PLACE WAS BROKEN OFF. IMPLANT REMAINS IN PLACE AFTER DOCTOR VERIFIED THE STABILITY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15426424 ↗
• MalfunctionDec 7, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT TIP OF SET SCREW SHEARED OFF. 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 12946301 ↗
• MalfunctionNov 2, 2020Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. IT WAS REPORTED THAT THE CENTER NUT OF CROSSLINK WAS STRIPPED. PRODUCT IS NOT IN PATIENT AND THERE WERE NO ISSUES PRIOR TO THE SURGERY. THE ISSUE HAPPENED DURING FINAL TIGHTENING OF THE IMPLANT. THERE WAS NO PATIENT SYMPTOMS REPORTED.

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

  MAUDE report 10768780 ↗
• MalfunctionDec 20, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INSTRUMENTATION AND FUSION SURGERY AT T11-L2 DUE TO SPINE DEGENERATION. INTRA-OP, WHILE IMPLANTATION THE CENTER BLUE NUT OF CROSSLINK STRIPPED. DEVICE HAS BEEN IMPLANTED 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 9501881 ↗
• 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 8177823 ↗
• MalfunctionNov 16, 2018Break; Break

  IT WAS REPORTED THAT T11-L3 FUSION WAS BEING PERFORMED ON PATIENT WITH L1 BURST FRACTURE. INTRA-OPERATIVELY, A NUT OF THE CROSSLINK SHEARED OFF. THE CROSSLINK WAS IMPLANTED AND THE OUTER SCREWS WERE BROKEN OFF. WHEN THE MIDDLE NUT OF THE CROSSLINK WAS BEING TIGHTENED, IT SHEARED OFF. DUE TO THIS, THE BROKEN CROSSLINK WAS COMPLETELY REMOVED AND REPLACED WITH A NEW ONE. NO FRAGMENT OF THE BROKEN IMPLANT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8077033 ↗
• MalfunctionMar 14, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS: L5- S1 DEGENERATIVE DISC PROCEDURE: POSTERIOR LATERAL INTERBODY FUSION (PLIF) LEVELS IMPLANTED: L5-S1 IT WAS REPORTED THAT ON (B)(6) 2018, INTRA-OP, WHILE IMPLANTING THE LATERAL TORQUE DOWN AND BREAK OFFS WERE A SUCCESSFUL BUT WHEN DOING THE FINAL TIGHTENING ON THE MIDDLE NUT, THE CENTER SCREW STRIPPED OUT AND DID NOT TOQUE DOWN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7337107 ↗
• MalfunctionMar 14, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS: L5- S1 DEGENERATIVE DISC PROCEDURE: POSTERIOR LATERAL INTERBODY FUSION (PLIF) LEVELS IMPLANTED: L5-S1 IT WAS REPORTED THAT ON (B)(6) 2018, INTRA-OP, WHEN PHYSICIAN PLACED A 41MM CROSSLINK IN BETWEEN THE SCREWS AND WENT TO TORQUE DOWN THE CROSSLINK ON THE LATERAL SIDES, THE CROSSLINK STRIPPED AND BROKE INTO PIECES. DOCTOR WAS ABLE TO OBTAIN ALL THE PIECES OF THE IMPLANT FROM THE WOUND. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7337106 ↗
• MalfunctionNov 17, 2017Break; Break

  PRE-OP DIAGNOSIS: REVISION LAMINECTOMY L3/4 PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION AT L2/5 IT WAS REPORTED THAT DURING SURGERY, THE INNER PORTION OF THE CROSSLINK SET SCREW WAS FOUND BROKEN AFTER FINAL TIGHTENING. CROSSLINK, SET SCREWS AND RODS WERE REPLACED. NO FRAGMENTS 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 7040947 ↗
• MalfunctionMar 17, 2017Device Damaged by Another Device; Device Damaged by Another Device

  PRE-OP DIAGNOSIS: LUMBAR SPONDYLOSIS PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION IT WAS REPORTED THAT DURING SURGERY, THE THREADS OF CROSSLINK GOT SHEARED DURING FINAL TIGHTENING. THE SURGEON WAS ABLE TO RETRIEVE ALL THE PIECES AND SAME WAS CONFIRMED WITH X-RAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6412544 ↗

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