CD HORIZON® Spinal System 7896545Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994291509), received between May 25, 2018 and Dec 12, 2018 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2018Break; Break

  TYPE OF PROCEDURE: LUMBAR FUSION LEVELS IMPLANTED: L2-S1 PRODUCT STATUS: PARTIALLY EXPLANTED IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE SCREWS AT S1 BROKE DUE TO WHICH THERE WAS NON-FUSION AT L5-S1. THE PATIENT ALSO REPORTED BACK PAIN DUE TO THIS EVENT. ALL THE OTHER LEVELS OF THE OPERATED SPINE HAD FUSED. ON (B)(6) 2018, A REVISION WAS PERFORMED WHEREIN THE BROKEN SCREWS WERE PARTIALLY EXPLANTED. THE BROKEN PIECES OF SCREW REMAINED IN S1 AND COULD NOT BE EXPLANTED. THE SCREWS BROKE 8-10MM BELOW THE SURFACE OF THE BONE. TREPHINES AND CONICAL EXTRACTION BOLTS WERE READY BUT THE SURGEON THOUGHT IT WOULD BE SAFER AND LESS INVASIVE TO PLACE THE TWO NEW SCREWS NEXT TO THE BROKEN SCREWS IS A SAFE AREA OF S1. THE TWO NEW SCREWS WERE PLACED IN A SAFE AREA AND WERE WELL FIXED. A SECOND IMAGING WAS PERFORMED TO CONFIRM PROPER PLACEMENT OF THE TWO NEW SCREWS. NO COMPLICATIONS WERE REPORTED AFTER THE REVISION SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8154321 ↗
• InjuryDec 12, 2018Break; Break

  TYPE OF PROCEDURE: LUMBAR FUSION LEVELS. IMPLANTED: L2-S1. PRODUCT STATUS: PARTIALLY EXPLANTED. IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE SCREWS AT S1 BROKE DUE TO WHICH THERE WAS NON-FUSION AT L5-S1. THE PATIENT ALSO REPORTED BACK PAIN DUE TO THIS EVENT. ALL THE OTHER LEVELS OF THE OPERATED SPINE HAD FUSED. ON (B)(6) 2018, A REVISION WAS PERFORMED WHEREIN THE BROKEN SCREWS WERE PARTIALLY EXPLANTED. THE BROKEN PIECES OF SCREW REMAINED IN S1 AND COULD NOT BE EXPLANTED. THE SCREWS BROKE 8-10MM BELOW THE SURFACE OF THE BONE. TREPHINES AND CONICAL EXTRACTION BOLTS WERE READY, BUT THE SURGEON THOUGHT IT WOULD BE SAFER AND LESS INVASIVE TO PLACE THE TWO NEW SCREWS NEXT TO THE BROKEN SCREWS IS A SAFE AREA OF S1. THE TWO NEW SCREWS WERE PLACED IN A SAFE AREA AND WERE WELL FIXED. A SECOND IMAGING WAS PERFORMED TO CONFIRM PROPER PLACEMENT OF THE TWO NEW SCREWS. NO COMPLICATIONS WERE REPORTED AFTER THE REVISION SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8154311 ↗
• MalfunctionMay 25, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN POSTERIOR LUMBAR INTER-BODY FUSION (PLIF) SURGERY AT L5-S1. POST-OP, S1 SCREW LOOSENING WAS OBSERVED. PER RADIOGRAPHIC REVIEW, THE PATIENT HAD A SUBTLE S1 SCREW LOOSENING THAT PROGRESSED ON FOLLOW-UP. PER INVESTIGATOR, THE SCREW LOOSENING HAS A ¿CAUSAL RELATIONSHIP¿ TO THE SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7543886 ↗
• MalfunctionMay 25, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN POSTERIOR LUMBAR INTER-BODY FUSION (PLIF) SURGERY AT L5-S1. POST-OP, S1 SCREW LOOSENING WAS OBSERVED. PER RADIOGRAPHIC REVIEW, THE PATIENT HAD A SUBTLE S1 SCREW LOOSENING THAT PROGRESSED ON FOLLOW-UP. PER INVESTIGATOR, THE SCREW LOOSENING HAS A ¿CAUSAL RELATIONSHIP¿ TO THE SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7543884 ↗