CD HORIZON® Spinal System 7640220Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074468204), received between Jan 23, 2018 and Jun 10, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR SPONDYLOLISTHESIS REDUCTION AND INTERNAL FIXATION. INTRA-OP, THE SCREW SLIPPED. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7585427 ↗
• MalfunctionJun 10, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR SPONDYLOLISTHESIS REDUCTION AND INTERNAL FIXATION. INTRA-OP, THE SCREW SLIPPED. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7585425 ↗
• MalfunctionJan 23, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FIXATION OF BONE GRATING IN THE SPINE DUE TO LUMBAR DISC HERNIATION. INTRA-OP, THE SET SCREW SLIPPED AND THE DOCTOR CHANGED IT TO STANDARD SET SCREW. THE DEVICE DID NOT BREAK. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7211638 ↗