CD Horizon™ Astute™ Spinal System 5630724Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20763000313344), received between Aug 18, 2021 and Sep 13, 2021 — classified as 2 malfunctions.

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

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

• MalfunctionSep 13, 2021Material Deformation; Scratched Material; Material Deformation; Scratched Material

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF CSR INVOLVED IN PSF (POSTERIOR SPINAL FUSION) PROCEDURE. LEVELS IMPLANTED: C2-T2. IT WAS REPORTED THAT RIGHT TAPERED ROD WAS BROKEN. NO BROKEN FRAGMENTS LEFT IN THE PATIENT'S BODY. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. PATIENT WAS NOT HOSPITALIZED PROLONG AS A RESULT OF THIS EVENT. REPORTED THEY MIGHT HAVE REMOVED THE NUT AND ROD FOR PERFORMING DECOMPRESSION ADDITIONALLY, AND THE RIGHT ROD WAS BROKEN WHEN PREPARING. PRODUCT WAS USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. REPORTED EVENT WAS REVISION SURGERY FOR CSR. INITIAL SURGERY WAS PERFORMED WITH NON-MDT PRODUCT. PROCEDURE INVOLVED IN INITIAL SURGERY WAS C3/4: PSF FOR PLASTY HIRAYAMA DISEASE. ADDITIONAL TREATMENT: FORAMINOTOMY C5 /6 /7 LEFT WAS PERFORMED. ADDITIONAL COMMENTS ABOUT THE EVENT: (B)(6) 2007 HIRAYAMA DISEASE. C3/4: PSF PERFORMED WITH NON-MDT PRODUCT (B)(6) 2021. CSR C2-T2: PSF NON-MDT PRODUCT REMOVAL COULD NOT BE PERFORMED. THE RIGHT HEAD CAME OFF ON ONE SIDE, AND THERE WAS NO CHOICE BUT TO LEAVE PRODUCT ON THE LEFT AND HYBRID WITH VS. ON (B)(6) 2021, RECEIVED ADDITIONAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460843 ↗
• MalfunctionAug 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED AFTER THE INITIAL L1/2/3 PSF PROCEDURE DONE ON (B)(6) 2018 IN A PATIENT DIAGNOSED WITH SPINAL CORD TUMOR. IT WAS REPORTED THAT DURING A REGULAR INSPECTION ON 26 JULY 2021 IT WAS CONFIRMED THAT THE SET SCREW ON THE LEFT SIDE OF L1 BACKED HAD BACKED OUT. A REVISION SURGERY IS SCHEDULED FOR (B)(6) 2021 TO EXPLANT THE PRODUCT. NO PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335237 ↗