CD HORIZON® Spinal System 5540430Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169007994), received between Feb 27, 2019 and Jul 3, 2020 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (6 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2020Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY DUE TO FRACTURE OF "LWK5". INTRA-OP, THE SET SCREW DID NOT FIX TO THE SCREW. THE THREAD WAS DAMAGED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. POST PRODUCT ANALYSIS, CROSS THREADING WAS OBSERVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10228861 ↗
• MalfunctionJul 26, 2019Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY AT L4-ILIAC. INTRA-OP, THE SET SCREW COULD NOT BE FIXED IN THE SCREW. AFTER TWO UNSUCCESSFUL ATTEMPTS TO FIX THE SET SCREWS, THE PHYSICIAN DECIDED TO SWITCH THE SCREWS TOO. FROM PHYSICIAN'S EXPERIENCE, HE DECIDED NOT TO IMPLANT THE SET SCREWS AT ALL; AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830446 ↗
• MalfunctionJul 26, 2019Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY AT L4-ILIAC. INTRA-OP, THE SET SCREW COULD NOT BE FIXED IN THE SCREW. AFTER TWO UNSUCCESSFUL ATTEMPTS TO FIX THE SET SCREWS, THE PHYSICIAN DECIDED TO SWITCH THE SCREWS TOO. FROM PHYSICIAN'S EXPERIENCE, HE DECIDED NOT TO IMPLANT THE SET SCREWS AT ALL; AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830423 ↗
• MalfunctionJul 26, 2019Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY AT L4-ILIAC. INTRA-OP, THE SET SCREW COULD NOT BE FIXED IN THE SCREW. AFTER TWO UNSUCCESSFUL ATTEMPTS TO FIX THE SET SCREWS, THE PHYSICIAN DECIDED TO SWITCH THE SCREWS TOO. FROM PHYSICIAN'S EXPERIENCE, HE DECIDED NOT TO IMPLANT THE SET SCREWS AT ALL; AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830409 ↗
• MalfunctionJul 26, 2019Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY AT L4-ILIAC. INTRA-OP, THE SET SCREW COULD NOT BE FIXED IN THE SCREW. AFTER TWO UNSUCCESSFUL ATTEMPTS TO FIX THE SET SCREWS, THE PHYSICIAN DECIDED TO SWITCH THE SCREWS TOO. FROM PHYSICIAN'S EXPERIENCE, HE DECIDED NOT TO IMPLANT THE SET SCREWS AT ALL; AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830398 ↗
• InjuryFeb 27, 2019Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS OSTEOSYNTHESIS SURGICAL PROCEDURE DUE TO SOME UNKNOWN REASONS. POST-OP, THE THREADS OF THE IMPLANTED SET SCREW WERE DAMAGED. PATIENT UNDERWENT REVISION SURGERY FOR THE REMOVAL OF ALLEGED DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8372811 ↗

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.