CD HORIZON® Spinal System 1555200500Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169272255), received between Jul 14, 2017 and Jun 30, 2023 — classified as 9 injuries, 2 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 16, 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.

• InjuryJun 30, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL FUSION T HERAPY. IT WAS REPORTED THAT THE ROD WAS BROKEN FROM THE INITIAL SURGERY AND WAS REPLACED IT WITH A NEW ROD. THERE WERE NO FURTHER COMPLICATIONS  OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17236644 ↗
• InjuryJan 30, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A ROD IMPLANTED IN A PATIENT. PROCEDURE PERFORMED WAS REVISION SURGERY OF BROKEN ROD. IT WAS REPORTED THAT THE REASON FOR EXPLANTING THE EXISTING IMPLANTED SCREW WAS DUE TO BROKEN ROD REVISION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13390251 ↗
• InjuryJan 2, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL FUSION AT T10-ILIAC. ON AN UNKNOWN DATE, POST-OP, THE ROD BROKE. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE BROKEN ROD WAS COMPLETELY EXPLANTED; AND WAS REPLACED WITH A NEW ONE. NO INFORMATION IS AVAILABLE ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9538874 ↗
• InjuryDec 27, 2019Migration; Migration

  PATIENT DEMOGRAPHICS: GENDER-MALE PRE-OPERATIVE DIAGNOSIS: PROCEDURE: LEVELS IMPLANTED:4 IT WAS REPORTED THAT THE PATIENT UNDERWENT 3 LEVEL OBLIQUE LUMBAR INTERBODY FUSION (OLIF) WITH 1 LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) DUE TO DEGENERATIVE SCOLIOSIS. POST-OP, ROD WAS SHIFTED OUT FROM MAS SCREW EVEN THROUGH THE SURGEON DID FINAL TIGHTENING FOR THE NON BREAK OFF SET SCREW. THE PATIENT UNDERWENT REVISION SURGERY. THE SURGEON DID THE REVISION BECAUSE THE BOTTOM ROD SHIFTED OUT FROM THE LAST MAS SCREW WHICH IS AT L5. HE CHANGED ONE NEW NON BREAK OFF SET SCREW FOR L5. AND FROM THE XRAY, IT SHOWED THAT THE BOTTOM ROD WAS OUT LONG ENOUGH FROM LAST SCREW .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9522683 ↗
• InjuryAug 16, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: PSEUDOARTHROSIS. HARDWARE FAILURE. HE UNDERWENT THE FOLLOWING PROCEDURES 1. FUSION EXPLORATION, 2. REMOVAL OF L1 PEDICLE SCREWS AND RODS, 3. L1-4 POSTERIOR ATHRODESIS, 4. MORSELIZED BONE ALLOGRAFT USE, 5. HEMOVAC DRAIN PLACEMENT. AS PER OPERATIVE NOTES" THE PATIENT PRESENTED FOR RIGHT HIP REPLACEMENT DUE TO FELL DOWN. THE MEDICAL RECORDS IN CONNECTION WITH THIS FALL NOTE THAT PATIENT HAD BEEN SUFFERING FROM A RIGHT PARAVERTEBRAL LUMP "MOST LIKELY SECONDARY TO HARDWARE (RODS) FAILURE WHICH WAS IMPLANTED ON (B)(6) 2017", LOOSENING CONTRIBUTED TO CAUSE HIM TO FALL AND ONGOING PAIN, WEAKNESS IN HIS LOW BACK AND SUSTAIN THE RESULTING INJURIES.

  Patient problems: Pain; Weakness

  MAUDE report 8901943 ↗
• InjuryAug 1, 2019Break; Break

  THE PATIENT UNDERWENT POSTERIOR SPINE FUSION SURGERY AT T11-PELVIS. POST-OP, THE IMPLANTED ROD BROKE. SOLID FUSION FUSED IN SOME AREAS BUT NOT THE LUMBOSACRAL JUNCTION. THE PATIENT SUFFERED WITH PAIN AS A RESULT OF THIS EVENT. PATIENT UNDERWENT REVISION SURGERY AS A RESULT OF THIS EVENT WHERE THE DEVICE HAS BEEN REMOVED FROM THE PATIENT BODY.

  Patient problems: Pain

  MAUDE report 8849552 ↗
• InjuryJul 16, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A FIXATION SURGERY AT T10-PELVIS USING SCREWS, SET SCREWS AND RODS. POST-OP, ON (B)(6) 2019, PATIENT FELL, DUE TO WHICH THE RODS SLIPPED OUT OF THE SCREWS AND THE SET SCREWS POPPED OUT. THE PATIENT ALSO HAD SOME FRACTURES IN THE SACRUM REGION FROM THE FALL. IT WAS BELIEVED THAT THE FLEXION FORCE FROM THE FALL CAUSED THE RODS TO SLIP AND SET SCREWS TO POP. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019, IN WHICH THE SCREWS AND THE SET SCREWS WERE REPLACED WITH NEW ONES. THE RODS WERE REUSED AND WERE LEFT IMPLANTED INSIDE THE PATIENT. CURRENT CONDITION OF THE PATIENT IS GOOD AND IS POST ONE WEEK WITH A SUCCESSFUL REVISION.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 8793026 ↗
• InjuryJul 16, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A FIXATION SURGERY AT T10-PELVIS USING SCREWS, SET SCREWS AND RODS. POST-OP, ON (B)(6) 2019, PATIENT FELL, DUE TO WHICH THE RODS SLIPPED OUT OF THE SCREWS AND THE SET SCREWS POPPED OUT. THE PATIENT ALSO HAD SOME FRACTURES IN THE SACRUM REGION FROM THE FALL. IT WAS BELIEVED THAT THE FLEXION FORCE FROM THE FALL CAUSED THE RODS TO SLIP AND SET SCREWS TO POP. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019, IN WHICH THE SCREWS AND THE SET SCREWS WERE REPLACED WITH NEW ONES. THE RODS WERE REUSED AND WERE LEFT IMPLANTED INSIDE THE PATIENT. CURRENT CONDITION OF THE PATIENT IS GOOD AND IS POST ONE WEEK WITH A SUCCESSFUL REVISION.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 8792908 ↗
• MalfunctionSep 26, 2017Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SPINAL SURGERY. POST-OP, ROD WAS FOUND TO BE BROKEN IN PATIENT'S SPINE. REPORTEDLY, RODS WERE BROKEN IN THE MIDDLE AND NOT AT A CONNECTION POINT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6892999 ↗
• MalfunctionSep 26, 2017Break; Break

  IT WAS REPORTED THAT ON: (B)(6) 2015: THE PATIENT PRESENTED WITH THORACOLUMBAR KYPHOSCOLIOSIS WITH SPINAL STENOSIS, SPONDYLOLISTHESIS AND SPINAL STENOSIS AND UNDERWENT THE FOLLOWING PROCEDURES: L5 LAMINECTOMY WITH REMOVAL OF ABNORMAL FACETS; L3-4, L4-5 DECOMPRESSION; L1-2, L2-3 POSTERIOR OSTEOTOMY; POSTERIOR SEGMENTAL INSTRUMENTATION T10 TO THE PELVIS USING PEDICLE SCREW INSTRUMENTATION; L5-S1 POSTERIOR LUMBAR INTERBODY FUSION USING SPACERS. AS PER OPERATIVE NOTES, "CENTRAL DECOMPRESSION WAS PERFORMED AT L3-4 AND L4-5 LEVELS AS WELL. THERE WAS SEVERE SPINAL CANAL STENOSIS. SEGMENTAL INSTRUMENTATION WAS THEN PLACED AT EACH LEVEL BETWEEN T10 AND THE PELVIS. S2 ALAR ILIAC SCREWS WERE PLACED IN THE PELVIS MEASURING 8.5MM IN DIAMETER AND 100 MM IN LENGTH. A POSTERIOR LUMBAR INTERBODY FUSION WAS THEN PERFORMED AT THE L5-S1 USING SPACERS MEASURING 22 MM IN LENGTH AND 12 MM IN HEIGHT. THESE CAGES WERE PACKED WITH HARVESTED MORSELIZED LAMINAR FRAGMENTS. ADDITIONAL BONE WAS PLACED IN THE LATERAL DECORTICATED GUTTERS BETWEEN T10 AND PELVIS. TO FACILITATE CORRECTION, OSTEOTOMIES WERE PERFORMED AT THE L1-2 AND L2-3 LEVELS. ON EACH SIDE, THE SCREWS WERE CONNECTED WITH A 5.5 MM COBALT CHROME ROD

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6892996 ↗
• InjuryJul 14, 2017Break; Break

  PRE-OP DIAGNOSIS: SCHEUERMANN'S KYPHOSIS IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OPERATIVELY, THE ROD AND THE SCREW BROKE. THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE BROKEN SCREW AND ROD.

  Patient problems: No Code Available

  MAUDE report 6713325 ↗