CD HORIZON® Spinal System 8115528Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00721902729522), received between Feb 7, 2017 and Feb 22, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionFeb 22, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP), DISTRIBUTOR (DIS) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE PRODUCT WAS BROKEN. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE EVENT OCCURRED WHEN THE PHYSICIAN MADE THE BREAK-OFF DURING IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577453 ↗
• MalfunctionDec 1, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DECOMPRESSION AND FUSION AT T2-T9. DURING SURGERY, THE CENTER NUT OF THE CROSSLINK SNAPPED OFF WHILE TORQUE WAS BEING APPLIED. NO FRAGMENTS OF THE PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7074007 ↗
• MalfunctionJun 2, 2017Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT PATIENT WITH OSTEOMYELITIS UNDERWENT LUMBAR FUSION. INTRA-OP, THE TORQUE LIMITING MECHANISM FAILED TO OPERATE PROPERLY CAUSING THE SCREW TO STRIP. THERE WERE NO FRAGMENTS REMAINING INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6607240 ↗
• MalfunctionMay 12, 2017Device Damaged by Another Device; Device Damaged by Another Device

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: SPINAL STENOSIS TYPE OF PROCEDURE OR TECHNIQUE USED: LUMBAR FUSION IT WAS REPORTED THAT THE TORQUE DRIVER DID NOT LIMIT THE TORQUE DURING SURGERY AND CAUSED THE CENTER LOCKING PART OF THE CROSSLINK TO STRIP. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6562579 ↗
• MalfunctionApr 28, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR SURGERY IN WHICH SURGEON HAD TO DRILL OUT FAILED DEVICE WITH METAL CUTTING BURR AND REPLACE WITH A NEW DEVICE. SET SCREW BROKE IN THE WRONG LOCATION CAUSING THE DEVICE TO BE STUCK ON THE ROD WITHOUT BEING ABLE TO TIGHTEN. ALL FRAGMENTS WERE REMOVED. COMPLICATIONS INVOLVED EXPLANTING THE BROKEN DEVICE UTILIZING A METAL CUTTING BURR. PATIENT ISSUE WAS RESOLVED. DIFFERENT CROSSLINK WAS USED IN PLACE OF BROKEN DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6529116 ↗
• MalfunctionFeb 7, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(60 2017, PATIENT WITH SPINAL STENOSIS UNDERWENT LUMBAR FUSION. INTRA-OP, THE DRIVER COULD NOT LIMIT THE TORQUE PROPERLY. DUE TO WHICH THE DRIVER APPLIED TOO MUCH PRESSURE AND THE CENTER NUT OF THE CROSSLINK STRIPPED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6306321 ↗