CD HORIZON® Spinal System 25740018590Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169414921), received between Aug 9, 2018 and Sep 26, 2023 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE ADDITIONAL SURGERY OF SCREW REPLACEMENT, ROD RECONNECTION AND TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) TO L4/5 & L5/S. INITIAL SURGERY (FIXATION) WAS PERFORMED ON (B)(6), 2022; ALTHOUGH THE TIMING WAS UNKNOWN WHEN THIS INCIDENT HAPPENED, THE BALLAST SET SCREW DISLODGEMENT AND SCREW LOOSENING OCCURRED; IT APPEARED SOMETHING LIKE HEMATOPOIESIS DUE TO THE REMAINING MOVEMENT, WHICH LED TO NEUROLOGICAL SYMPTOMS. IMPLANT DEBRIS REMAINS IN PATIENT. EXPLANT COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED DUE TO THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT LOOSE SCREWS ON BOTH SIDES OF SAI AND DISLODGING OF THE NUT ON ONE SIDE OF THE SAI. PRE OP DIAGNOSIS DETAILS OF THIS EVENT WAS RHEUMATOID ARTHRITIS.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 17815487 ↗
• InjurySep 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE ADDITIONAL SURGERY OF SCREW REPLACEMENT, ROD RECONNECTION AND TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) TO L4/5 & L5/S. INITIAL SURGERY (FIXATION) WAS PERFORMED ON (B)(6) 2022; ALTHOUGH THE TIMING WAS UNKNOWN WHEN THIS INCIDENT HAPPENED, THE BALLAST SET SCREW DISLODGEMENT AND SCREW LOOSENING OCCURRED; IT APPEARED SOMETHING LIKE HEMATOPOIESIS DUE TO THE REMAINING MOVEMENT, WHICH LED TO NEUROLOGICAL SYMPTOMS. IMPLANT DEBRIS REMAINS IN PATIENT. EXPLANT COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED DUE TO THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT LOOSE SCREWS ON BOTH SIDES OF SAI AND DISLODGING OF THE NUT ON ONE SIDE OF THE SAI. PRE OP DIAGNOSIS DETAILS OF THIS EVENT WAS RHEUMATOID ARTHRITIS.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 17807486 ↗
• InjuryMay 15, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD L5/S FUSION F AILURE. IT WAS REPORTED THAT PATIENT HAD  S1 SCREW REMOVAL S2AI SCREW REPLACEMENT DUE TO S1 SCREW LOOSENING S2AI SET SCREW DISLOCATION. PATIENT HAD L5/S FUSION FAILURE DUE TO SCREW LOOSENING AND DISLOCATION. THERE WAS NO PATIENT SYMPTOM REPORTED AFTER REVISION SURGERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16929044 ↗
• InjuryApr 3, 2023Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY F OR L5/S BONE FUSION FAILURE, S2AI SET SCREW DISLODGEMENT. DATE OF INITIAL SURGERY- FIRST TIME: (B)(6) 2021, SECOND TIME: (B)(6) 2022 INITIAL SURGERY OR THE PROCEDURE TAKEN: TH4-S2AI L4/5/S PLIF (ADULT SPINAL DEFORMITY) IT WAS REPORTED THAT THE PATIENT WAS INITIALLY FIXED WITH TH4-S2AI, THEN IT WAS ONCE REPLACED WITH S2AI BY REOPERATION AND CONNECTED WITH MRC WITH DOUBLE S2AI ON BOTH SIDES AND PARALLEL ROD EXTENSION TO THE CRANIAL SIDE.  RIGHT SET SCREW CAME OFF AND REPLACEMENT RE-OPERATION WAS PERFORMED. THE INNER ROD WAS EXTENDED TO L2 AND IT WAS IN CONTACT WITH THE MRC, SO IT WAS DEPLOYED BELOW L2. WHEN ALL THE IMPLANTS WERE EXPOSED, IT WAS FOUND THAT THE TWO S2AI SET SCREWS ON THE RIGHT SIDE HAD COME OFF AS SHOWN IN THE XRAY, BUT THE SET SCREW ON THE LEFT SIDE HAD ALSO COME OFF ON THE CRANIAL SIDE. IN ADDITION, THE S2AI SCREWS ON BOTH CAUDAL SIDES HAD RODS DETACHED FROM THE HEAD ON BOTH SIDES. ON THE LEFT SIDE, THE SET SCREW WAS NOT DETACHED, BUT THE ROD WAS DETACHED FROM THE HEAD, WHICH SURPRISED THE DOCTOR. FIRST, THE PROLOCK BETWEEN L4/5 WAS RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16661499 ↗
• MalfunctionMar 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT WHICH IS USED IN POSTERIOR SPINAL FUSION FOR SCOLIOSIS CORRECTION SPINAL THERAPY FOR SCOLIOSIS. IT WAS REPORTED THAT THE SET SCREW APPEARS TO HAVE COME AWAY FROM THE BALLAST SCREWHEAD. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT IN THE FIRST FOLLOW UP, THE RIGHT SIDE ROD AND BALLAST SCREW HEAD NOT CONNECTED AND DURING 2ND FOLLOW UP APPOINTMENT, SET SCREW HAS COME AWAY FROM BALLAST SCREW HEAD. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO MALFUNCTION ASSOCIATED WITH THE ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535274 ↗
• InjuryMay 20, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF RIGHT S1 S2AI SET SCREW CAME OFF. IT WAS REPORTED THAT IT WAS A PATIENT WHO WAS PERFORMED TH10-S2AI WITH L3/4/5/S PLIF ON (B)(6) 2017, AFTER THE OPERATION, THE SET SCREW ON THE RIGHT SIDE OF S1 / 2 BACKED OUT (CAME OFF). WHEN OPENED THE WOUND WITH REOPERATION, THE SET SCREW OF L5 ON THE LEFT SIDE ALSO BACKED OUT, THE ROD (5.5MM DIAMETER, COBALT-CHROMIUM) WAS BROKEN AT L5 / S ON THE LEFT SIDE. AS FOR THE SET SCREWS, ALL THREE HAD COMPLETELY BACKED OUT, AND THE ROD WAS SLIGHTLY FLOATING, BUT IT WAS CONTAINED WITHIN THE SCREW HEAD. AS PER PHYSICIAN BONE UNION MIGHT NOT BE ACHIEVED. DURING THE REOPERATION, ALL SCREWS WERE REPLACED AT THREE POSITIONS THAT SET SCREWS HAD BACKED OUT , THE ROD WAS CONNECTED BY MRC ON BOTH SIDES. THE LEFT L5 SCREW WAS REPLACED, THE RIGHT S1 S2 SCREW WAS REPLACED, AND THE ROD WAS CUT BETWEEN THE RIGHT L5 / S AND WAS RE-FIXED ON BOTH SIDES USING WITH MRC. THERE IS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854515 ↗
• InjuryFeb 25, 2020Migration; Migration

  POST-OP, THE SET SCREW AT S2 ON THE LEFT SIDE BACKED OUT. PATIENT HAD TO UNDERWENT REVISION SURGERY FOR ITS FIXATION. DURING THE REVISION SURGERY, THE ALLEGED SET SCREW WAS REPLACED. AT THE POINT WHERE SET SCREW BACKING OUT OCCURRED, THE ROD HAD BEEN ENGAGED INSIDE THE SCREW HEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9749434 ↗
• InjuryOct 7, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY DUE TO DEGENERATIVE LUMBAR SCOLIOSIS. INTRA-OP, AFTER IMPLANTING THE ILIAC SCREW, IT WAS FOUND TO BE DEVIATED WHEN CHECKING THE X-RAY. HENCE, ANESTHESIA WAS PERFORMED AGAIN, AND THE REPLACEMENT OF THE SCREW WAS PERFORMED. THERE WAS NO PROBLEM OBSERVED ON THE X-RAY AFTER THE OPERATION. ALTHOUGH THERE WAS A DELAY OF MORE THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME DUE TO THIS EVENT, NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT'S ISSUE HAS NOW BEEN REPORTED TO HAVE RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9160807 ↗
• InjuryAug 9, 2018Migration or Expulsion of Device; Device Slipped; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH KYPHOSIS AND UNDERWENT POSTERIOR FUSION AT L2/S2AI. POST-OP, THE WOUND OPENED DUE TO SOME REASONS AFTER THE OPERATION , THE PATIENT UNDERWENT CONTINUOUS CLEANING. IT WAS CONFIRMED THAT THE SCREW BACKED OUT WHEN PERFORMING X-RAY AND CT. SINCE THE WOUND WAS OPEN AND IT WAS ABLE TO REMOVE THE PRODUCT ON THE SPOT, REVISION FUSION BEFORE WOUND CLOSURE WAS REQUESTED, SO REVISION FUSION WAS PERFORMED. REPLACEMENT WAS PERFORMED AND THE ITEM WAS DISCARDED. THERE WAS INFECTION AND THE PATIENT RECEIVED RE-OPERATION SEVERAL TIMES. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: Post Operative Wound Infection; Unspecified Infection; Wound Dehiscence

  MAUDE report 7766751 ↗