CD HORIZON® Spinal System 8690060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00721902183553), received between Dec 22, 2017 and Nov 12, 2020 — classified as 4 injuries, 2 malfunctions.

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

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 12, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH L4-S1 FUSION FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW BROKE. IMPLANTED AND REPLACED WITH A NEW SCREW. THE DEVICE WAS REPLACED AND THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THE PATIENT HAD BACK PAIN AS SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 10827490 ↗
• MalfunctionNov 12, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH L4-S1 FUSION FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW BROKE. IMPLANTED AND REPLACED WITH A NEW SCREW. THE DEVICE WAS REPLACED AND THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THE PATIENT HAD BACK PAIN AS SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 10827485 ↗
• InjuryDec 26, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS:DEGENERATIVE DISEASE PROCEDURE:OPEN SURGERY IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST -OP, THE ROD WAS BROKEN. THE PATIENT HAD ACHIEVED SOLID FUSION. NO PATIENT COMPLICATION WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7145443 ↗
• InjuryDec 26, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS:DEGENERATIVE DISEASE PROCEDURE:OPEN SURGERY IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, ROD BROKE. THE BROKEN ROD WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7145442 ↗
• InjuryDec 22, 2017Break; Break

  PRE-OP DIAGNOSIS; DEGENERATIVE DISEASE TYPE OF PROCEDURE OR TECHNIQUE USED: OPEN SURGERY IT WAS REPORTED THAT POST-OP, THE ROD WAS REPORTED DAMAGED. THE PATIENT HAD ACHIEVED SOLID FUSION. PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT WAS UNKNOWN. HOWEVER, A ROD REPLACEMENT SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient; Pain

  MAUDE report 7141661 ↗
• InjuryDec 22, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT PATIENT WAS PREOPERATIVELY DIAGNOSED WITH DEGENERATIVE DISEASE AND UNDERWENT UNSPECIFIED SURGERY. POST-OP, THE ROD WAS DAMAGED. HENCE, A REVISION SURGERY WAS PERFORMED TO REPLACE THE ROD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7141504 ↗