CD HORIZON® Spinal System 8116445Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00721902819674), received between Dec 24, 2016 and Nov 16, 2021 — classified as 6 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 18, 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 16, 2021Break; Device Slipped; Break; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- LUMBAR SPINAL STENOSIS INVOLVED IN THE POSTERIOR LUMBAR SCREW IMPLANTATION SURGERY. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE CROSSLINK SCREW NUT SLIPPED, WHICH CAUSED THE SCREW TO BE UNABLE TO BE TIGHTENED OR UNSCREWED. PRODUCT BROKE AND NO FRAGMENTS LEFT IN THE PATIENT'S BODY. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PATIENT WAS ALIVE AND NO INJURY. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT DELAY IN OVERALL PROCEDURE TIME WAS ABOUT HALF AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12818031 ↗
• MalfunctionApr 4, 2019Break; Break

  IT WAS REPORTED THAT INTRA-OP, WHEN THE CROSS-LINK WAS INSTALLED, THE SCREW PLUG BROKE AT THE NON-BREAKING POINT WHEN THE SCREW PLUG WAS SCREWED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8483738 ↗
• MalfunctionMar 31, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING POSTERIOR LUMBAR INTERBODY FUSION DUE TO LUMBAR DISC PROTRUSION. INTRA-OP, WHEN THE SCREW WAS SCREWED, THE SCREW PLUG BROKE AT THE NON-BREAKING POINT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8468025 ↗
• MalfunctionMar 31, 2019Break; Break

  IT WAS REPORTED THAT INTRA-OP, WHEN THE CROSSLINK WAS BEING INSTALLED, THE SCREW PLUG BROKE AT THE NON-BREAKING POINT. THE PRODUCT CAME IN CONTACT WITH THE PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8468008 ↗
• MalfunctionMar 30, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION DUE TO LUMBAR DEGENERATIVE DISEASE. INTRA-OP, WHEN THE SCREW PLUG WAS SCREWED, IT BROKE AT THE NON-BREAKING POINT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8467916 ↗
• MalfunctionDec 24, 2016Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE TO CORRECT SPINAL DEFORMITY. INTRA-OPERATIVELY,THE WASHER UNDER THE MIDDLE SET SCREW CAME OFF DURING FINAL TIGHTENING FROM CROSSLINK. NO FRAGMENTS WERE REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6203460 ↗