CD HORIZON® Spinal System 5540130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169007987), received between Aug 21, 2017 and Aug 21, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Metal Shedding Debris” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2017Metal Shedding Debris; Metal Shedding Debris

  IT WAS REPORTED THAT PATIENT WITH PRE OPERATIVE DIAGNOSIS OF SPONDYLOLISTHESIS AT L4/5 UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUS ION AT L4 AND L5. INTRA-OP, DURING REDUCTION OF SPONDYLOLISTHESIS,THE LEFT L4 REDUCTION MULTI AXIAL SCREW STRIPPED THE SET SCREW. PRODUCTS CAME IN CONTACT WITH THE PATIENT. STRIPPED PIECES OF THE IMPLANT WAS WASHED OUT WITH WATER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6806669 ↗
• MalfunctionAug 21, 2017Metal Shedding Debris; Metal Shedding Debris

  IT WAS REPORTED THAT PATIENT WITH PRE OPERATIVE DIAGNOSIS OF SPONDYLOLISTHESIS AT L4/5 UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUS ION AT L4 AND L5.INTRA-OP, DURING REDUCTION OF SPONDYLOLISTHESIS,THE LEFT L4 REDUCTION MULTI AXIAL SCREW STRIPPED THE SET SCREW. PRODUCTS CAME IN CONTACT WITH THE PATIENT. STRIPPED PIECES OF THE IMPLANT WAS WASHED OUT WITH WATER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6806666 ↗

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.