CD HORIZON® Spinal System 7543650Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00721902857546), received between Jun 21, 2018 and Jun 21, 2018 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K031655); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR INTERNAL FIXATION DUE TO LUMBAR DEGENERATION. INTRA-OP, THE SCREW SLIPPED. THE DEVICE CAME IN CONTACT WITH THE PATIENT BUT WAS EXPLANTED COMPLETELY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7624873 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031655. One submission often covers many models, so check the product and lot details in each record.

• Z-2874-2011 · Jun 28, 2011 · Terminated
  CD HORIZON (R) LEGACY (TM) FAS, REF 7542535, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization an