CD HORIZON® Spinal System 25740018570Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169414907), received between Sep 4, 2018 and May 7, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPI NAL FUSION. IT WAS REPORTED THAT THE SET SCREW WAS REMOVED DUE TO CROSS-THREADING AFTER THE FINAL FIXATION OF THE S2AI SCREW. AFTERWARDS, A NEW SET SCREW WAS INSERTED AND THE FINAL FIXATION WAS ATTEMPTED, BUT A BREAK COULD NOT BE MADE; THE S2AI SCREW WAS REPLACED WITH A NEW ONE, AND THE FINAL WAS RE-FINALIZED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257758 ↗
• InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF ADULT DEFORMITY. IT WAS REPORTED THAT THE SET SCREW OF S2AI SCREW BACKED OUT, SO ROD HAD REACHED NEAR THE SKIN AND IT WAS SUSPECTED TO BE INFECTED FROM THERE, ROD WAS CUT BETWEEN L3-4 AND THE SCREW BELOW L4 WAS REMOVED. THE FIXATION ABOVE L3 WAS REMAINED AS IT WAS. THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT HEALTH DAMAGE IN THE PATIENT WAS REPORTED. ROD AND BREAK-OFF SET SCREW IS PARTIAL EXPLANTED. OTHER TWO SCREWS WERE COMPLETELY EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10647709 ↗
• InjuryJun 24, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  PRE OP DIAGNOSIS: ROD BROKEN AND SCREW BACK-OUT PROCEDURE PERFORMED: T9/IL POSTERIOR FIXATION, L4 ANTERIOR SUBTOTAL REMOVAL AND PLACEMENT OF T2 POST OP, THE RIGHT ROD BROKE OFF AND THE PLUG ON THE LEFT SIDE OF S2AI BACKED OUT. DUE TO THIS PATIENT SUFFERED LOWER BACK PAIN. AS A RESULT OF THIS REVISION SURGERY WAS PERFORMED, FIXATION WAS PERFORMED FROM THE POSTERIOR SIDE, AND THE PLUG AND THE ROD WERE REMOVED. THE LEFT BA THAT BACKED OUT WAS REMOVED AND REPLACED WITH F9.5/70MM, AND F6.5/40MM WAS INSERTED TO THE L4 RIGHT, AND CONNECTION WAS PERFORMED AGAIN WITH THE F6.0COCR ROD. GC WAS PLACED AT L4. THE GC AT T11/12 WAS ONLY REMOVED AND NOT REINSERTED. THERE WAS A DELAY OF MORE THAN 60 MIN IN OVERALL PROCEDURE. PATIENT WAS HOSPITALIZED.

  Patient problems: Pain

  MAUDE report 10187507 ↗
• InjuryMar 17, 2020Migration; Migration

  PRE OP DIAGNOSIS: SCREW DEVIATED AND SET SCREW HAS COME OFF PROCEDURE PERFORMED: POSTERIOR SPINAL FUSION (PSF) LEVELS IMPLANTED: S2 POST OP, THE REPORTED SCREW BACKED OUT COMPLETELY AND AS A RESULT OF THIS, PATIENT UNDER WENT REVISION SURGERY FOR ITS REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9840673 ↗
• InjuryDec 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCREW REMOVAL AND INSERTION, CONNECTION OF THE SCREW AND ROD AT L2-L5, S1-S2AL DUE TO STENOSIS. POST-OP, PATIENT HAD PELVIC FRACTURE BECAUSE OF THIS THE PATIENT TUMBLED AND UNDERWENT TREATMENT OF ILIAC FRACTURE. THEREAFTER THE SCREWS AT L2-L5, S1-S2AL WERE REMOVED AND TWO LONG SCREWS WERE INSERTED ON EACH SIDE (RIGHT:2 LEFT:2) INTO THE ILIAC FOR THE PURPOSE OF FRACTURE TREATMENT, AND FIXATION WAS PERFORMED AGAIN. THEREAFTER, CONNECTION OF THE SCREWS AT L3-4 AND THE ROD WAS PERFORMED. THERE WAS NO PRODUCT MALFUNCTION AS THE ADDITIONAL TREATMENT FOR PELVIC FRACTURE CAUSED BY PATIENT TUMBLED AFTER THE OPERATION THE PATIENT WAS UNABLE TO WALK BECAUSE OF THE PELVIC FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 9528853 ↗
• InjuryDec 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FIXATION SPINAL SURGERY AT L3/S2 DUE TO SOME UNSPECIFIED REASONS. POST-OP, SCREW ON THE RIGHT SIDE S1 HAD RUPTURED THE INNER SIDE. PATIENT UNDERWENT REVISION SURGERY AS A RESULT OF THIS EVENT. IN WHICH, DIRECTION OF SCREW HAS BEEN CHANGED AND REINSERTED AGAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9488229 ↗
• InjurySep 4, 2018Material Deformation; Material Deformation

  PRE-OPERATIVE DIAGNOSIS: PROXIMAL JUNCTIONAL KYPHOSIS PROCEDURE: IMPLANT REPLACEMENT AND DEBRIDEMENT LEVELS IMPLANTED: S2 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, AFTER FUSION WAS PERFORMED ON T10/S2AI DUE TO ADULT SPINE DEFORMITY, INFECTION OCCURRED (CORYNEBACTERIA). AT THE TIME OF DEBRIDEMENT, IT WAS CONFIRMED THAT THE SET SCREW BACKED OUT. THIS TIME THE REPLACEMENT OF THE REPORTED PRODUCT WAS ALSO PERFORMED ALONG WITH THE REPLACEMENT OF THE ROD. REVISION SURGERY WAS PERFORMED AS A RESULT OF THE EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 7841134 ↗