CD HORIZON® Spinal System 9010000849 (UDI 00643169359987)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169359987), received between Dec 28, 2016 and Sep 1, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539519 ↗
• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR L4-S1 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL THERAPY. IT WAS REPORTED THAT THE LOCKING MECHANISM ON ROD HOLDER IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE DEVICE WAS USED MANY TIMES AND NOT AN INITIAL DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569600 ↗
• MalfunctionFeb 6, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LATERAL LUMBAR INTERBODY FUSION AT LEVELS 3/5. IT WAS REPORTED THAT THE INSTRUMENT BROKE. 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 24276437 ↗
• MalfunctionJun 24, 2021Break; Mechanical Problem; Break; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION FOR PPS. IT WAS REPORTED THAT THE ROD GRIPPING WAS WEAK. WHEN TURNED THE DIAL TO MAKE ADJUSTMENTS, THE MECHANISM OF ONE OF THE TWO INSTRUMENTS BROKE AND THE SHAFT INSIDE WAS BROKEN. PRODUCT WILL BE RETURNED. THE PATIENT WAS NOT ASSOCIATED WITH THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE GRIPPING OF THE ROD INSERTERS THAT ARE LONG-TERM CONSIGNMENTS WAS LOOSE. ACCORDING TO SURGICAL TECHNIQUE, THE STRENGTH WAS ADJUSTED WITHOUT GRIPPING ROD. THE INTERNAL MECHANISM OF ONE INSERTER WAS DAMAGED, AND ANOTHER ONE WAS NOT DAMAGED, BUT THE GRIPPING FORCE DID NOT IMPROVE MUCH. IT WAS MANAGED TO DEAL WITH THE OPERATION BY USING THE ROD INSERTER THAT DID NOT DAMAGE, AND THE OPERATION WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PRE-OP DIAGNOSIS WAS KYPHOSIS. THE PRODUCTS WERE USED IN THE PATIENT. THERE WAS NO HEALTH INJURY. THERE WAS 10-15 MINUTES DELAY IN THE PROCEDURE DUE TO THE MALFUNCTION OF MDT DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055862 ↗
• MalfunctionJul 6, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH L1 LUMBAR FRACTURE FOR T12-L2 PERCUTANEOUS STABILIZATION. IT WAS REPORTED THAT THE ROD WAS LOADED ONTO ROD HOLDER PRIOR TO USING THE INSTRUMENT. ROD WAS LOOSE IN HOLDER, AND HOLDER REQUIRED TIGHTENING. SCREWDRIVER WAS USED TO TIGHTEN THE SYSTEM AND AN AUDIBLE CLICK WAS MADE BY THE HOLDER. THE SPRING SYSTEM THAT HOLDS THE ROD BROKE AND WAS NOT ABLE TO HOLD ROD SECURELY AT ALL. THE PRODUCT DID NOT COME IN CONTACT WITH THE PATIENT. THERE WERE NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND AN ALTERNATIVE HOLDER WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10237899 ↗
• MalfunctionSep 11, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR VERTEBRAL BODY REPLACEMENT AND POSTERIOR PERCUTANEOUS PEDICLE SCREW FIXATION DUE TO "L" TUMOR. INTRA-OP, THE RETAINING RING OF THE PERCUTANEOUS ROD INSERTER CAME OFF; AND THE ROD INSERTER CLAMP HAD BEEN PULLED OUT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE BROKEN ROD INSERTER REMAINED INSIDE THE PATIENT. IT IS UNKNOWN IF THERE WERE ANY PATIENT COMPLICATIONS OR NOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8991631 ↗
• MalfunctionFeb 11, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS POSTERIOR FUSION AT TH9-L3 DUE TO COMPRESSION FRACTURE AT TH12 AND L1. INTRA-OP, THE INSERTER COULD NOT FIRMLY GRIP THE ROD DURING PERCUTANEOUS INSERTION. THE INSERTER WAS THEN REMOVED AND ITS TENSION WAS RE-TIGHTENED STRONGLY. THE SURGEON THEN INSERTED THE ROD BY HOLDING THE ROD WITH ONE HAND; AND COMPLETED THE INSERTION SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324788 ↗
• MalfunctionFeb 8, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY VERTEBRAL BODY FRACTURE AT L1 AND UNDERWENT VERTEBROPLASTY AND FIXATION AT TH11-L3. DURING THE SURGERY, PROBLEM OCCURRED WHEN GRIPPING THE ROD. IT SEEMED THAT THE TIP OF THE ROD INSERTER NARROW WAS BROKEN AND THAT THE ROD AND THE INSERTER WERE NOT TIGHTLY FITTED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE BROKEN INSERTER REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8319492 ↗
• InjuryJun 28, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LEG PAIN DUE TO DEGENERATIVE SCOLIOSIS AND UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION. DURING SURGERY, THE ROD INSERTER COULD NOT GRASP STRONGLY AND WAS BROKEN BUT IT WAS ABLE TO CONNECT WITH THE ROD. BECAUSE THE PRODUCT WAS WEAK TO GRIP THE ROD, ADJUSTMENT WAS PERFORMED DURING THE OPERATION. ADJUSTMENT WAS MADE WITH RAISING THE LATCH BY TWO STEPS, BUT IT CAN NOT INTERLOCK EVEN IF THE ADJUSTMENT TENSION KNOB WAS TURNED. THE ROD WAS INSERTED FINALLY IN A STATE OF THE PRODUCT LOOSENED. FRAGMENTS OF THE BROKEN PART REMAINED IN THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED TO BE UNKNOWN. THERE WAS A DELAY OF LESS THAN 60 MINUTES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7645151 ↗
• MalfunctionDec 30, 2016Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PATIENT WITH BURST FRACTURE AT L1,2 UNDERWENT TH12-L3 POSTERIOR SPINAL FUSION. INTRA-OP, DURING INSERTION OF ROD, THE ROD INSERTER COULD NOT GRIP A ROD FIRMLY. THE SURGEON TRIED TO TIGHTEN THE ROD INSERTER FOR ITS GRIPPING FORCE USING DRIVER BUT IT COULD NOT BE TIGHTEN THEN THE ROD INSERTER COULD NOT GRIP A ROD ANYMORE. THERE WAS ANOTHER SURGERY THAT WAS SCHEDULED USING THE ROD INSERTER ON THE SAME DAY SO THAT INSERTER WAS USED IN THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6215014 ↗
• MalfunctionDec 28, 2016Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PATIENT WITH LUMBAR SPINAL CANAL STENOSIS AND LUMBAR SPONDYLOLISTHESIS UNDERWENT POSTERIOR SPINAL FUSION AT L3-5. INTRA-OP, AFTER INSERTION OF PEDICLE SCREWS AT LEFT SIDE OF L3-5, THE SURGEON ATTEMPTED TO ATTACH ROD TO ROD INSERTER BUT THE ROD INSERTER'S GRIPPING FORCE WAS NOT ENOUGH SO THE TENSION KNOB WAS ADJUSTED. AFTER THE ADJUSTMENT, WHEN THE SURGEON TRIED TO PERFORM ROD INSERTION THE ROD CAME OFF FROM IT, ALTHOUGH HE DID NOT LIFT UP THE LATCH LEVER OF THE INSERTER. THE CAME OFF ROD WAS REMOVED. ROD WAS AGAIN TRIED TO BE ATTACHED TO THE INSERTER AT RIGHT SIDE BUT SAME EVENT HAPPENED AGAIN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6208022 ↗