CD HORIZON® Spinal System 55840009570Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169005365), received between Nov 16, 2016 and Nov 16, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K113174); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2016Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY FOR ROD REVISION AT L1-L2,REQUIRE ROD CHANGE AND ROD CONNECTOR. PATIENT ALREADY HAD IMPLANTS IN FROM T2-PELVIS WITH SEVERAL SCREWS MISSING THROUGHOUT THE MIDDLE OF THE CONSTRUCT. PLAN WAS TO REPLACE SCREWS IN THE LOWER HALF OF THE PATIENT WITH OTHER SCREWS,THEN ADD AXIAL CONNECTORS TO THE EXISTING UPPER CONSTRUCT AND PLACE SCREWS ON THE LOWER HALF. INTRA OPERATIVE A TIP OF DRIVER BROKE IN THE SCREW SO HE PLACED THE SMALL PIECE OF ROD INTO THE SCREW, PUT A SET SCREW BACK ON TO MAKE THE SCREW FIXED, THEN PLACED THE COUNTER TORQUE OVER THE HEAD OR THE SCREW TO GET THE SCREW IN. THIS WAS WHEN THE HEAD OF THE SCREW BROKE. PART OF THE THREAD WAS STICKING OUT SO HE CUT IT OFF WITH A BURR SO IT WAS FLUSH WITH THE PELVIS. DOCTOR DID NOT PLACE ANOTHER SCREW IN THE PELVIS ON THAT SIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6105101 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113174. One submission often covers many models, so check the product and lot details in each record.

• Z-2603-2018 · Jul 9, 2018 · Terminated
  Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.