CD HORIZON® Spinal System 7049855Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00613994171108), received between Aug 10, 2017 and Feb 6, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OPEN SURGERY FOR SPINAL STENOSIS. IT WAS REPORTED THAT SET SCREW WAS DAMAGED AS THE THREADS WERE SLIPPERY. 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 21321466 ↗
• MalfunctionJan 22, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OPEN LUMBAR SPI NAL THERAPY FOR LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT THE DEVICE WAS DAMAGED. THERE WAS NO PATIENT SYMPTOM REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SETSCREW WAS SCREWED IN AND OCCURRED SLIPPERY THREAD AND FELT ABNORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208093 ↗
• MalfunctionJan 6, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING DECOMPRESSION AND INTERNAL FIXATION FOR LUMBAR TUMOR. IT WAS REPORTED THAT SCREW BROKE. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE REP THAT SELF-BREAKING SET SCREW WAS DAMAGED AND SLIPPED. PRODUCT CAME IN CONTACT WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21088415 ↗
• MalfunctionDec 29, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN INCISIONAL DECOMPRESSION AND INTERNAL FIXATION FOR LUMBAR TUMOR. IT WAS REPORTED THAT DURING CMAS SURGERY, THE SACROILIAC SET SCREW WAS TIGHTENED. AFTER THE SET SCREW WAS BROKEN, DURING THE PROCESS OF TIGHTENING THE LUMBAR 5 SCREW, THE SCREW WAS FOUND TO BE PULLED OUT. ONLY THE SACROILIAC SET SCREW COULD BE REMOVED AGAIN, AND THE LUMBAR 5 SCREW COULD BE REINSERTED, IT CAUSED THE SET SCREW DAMAGED. THE PRODUCT HAS BEEN EXPLANTED. IT WAS REPORTED THAT AFTER TIGHTENING THE SCREW PLUG, IT WAS FOUND THAT THE SCREW EXITED. SO THE SCREW PLUG NEEDED TO BE REMOVED AGAIN, AND THE SCREW WAS RE-INSERTED, RESULTING IN DAMAGE TO THE SCREW PLUG. NO PATIENT SYMPTOMS WERE REPORTED. NO ADDITIONAL SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032306 ↗
• MalfunctionJul 16, 2020Break; Break

  INFORMATION RECEIVED FROM INITIAL REPORTER VIA MEDTRONIC FIELD REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING THE INTRA-OP FOR A PRE-OP DIAGNOSIS OF SPINAL FRACTURE. IT WAS REPORTED THAT THE INSTRUMENT OR IMPLANT WAS BROKEN DURING THE INTRA-OP. IT WAS ALSO MENTIONED THAT THERE WERE NO FRAGMENTS WERE LEFT INSIDE THE PATIENT BODY. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT WAS PERFORMED DUE TO THIS EVENT. THE IMPLANT STATUS REMAINED AS EXPLANTED ¿ COMPLETE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THIS EVENT. THERE WERE NO COMPLICATIONS TO PATIENT/PHYSICIAN REPORTED DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10282011 ↗
• MalfunctionJul 12, 2018Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SPINAL INTERNAL FIXATION DUE TO LUMBAR DEGENERATION. INTRA-OP, THE SCREW SLIPPED AND COULD NOT BE TIGHTENED. THE SCREW CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7681849 ↗
• MalfunctionMar 6, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INTERNAL FIXATION OF SACROILIAC FRACTURES. DURING THE SURGERY, TWO SET SCREWS SLIPPED IN THE PROCESS OF INSERTING. THE FIX EFFECT WAS NOT GOOD. BOTH THE SET SCREWS WERE COMPLETELY EXPLANTED AND REPLACED WITH NEW SCREW. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7319581 ↗
• MalfunctionMar 6, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INTERNAL FIXATION OF SACROILIAC FRACTURES. DURING THE SURGERY, TWO SET SCREWS SLIPPED IN THE PROCESS OF INSERTING. THE FIX EFFECT WAS NOT GOOD. BOTH THE SET SCREWS WERE COMPLETELY EXPLANTED AND REPLACED WITH NEW SCREW. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7319580 ↗
• MalfunctionMar 6, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR TUMOUR AND UNDERWENT UNSPECIFIED SURGERY.DURING SURGERY, THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED TO BE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316563 ↗
• MalfunctionMar 6, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR SPONDYLOLISTHESIS AND UNDERWENT AN UNSPECIFIED SURGERY. DURING SURGERY, LOCKING SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316560 ↗
• InjurySep 21, 2017Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT, PATIENT COMPLAINED OF PAIN DUE TO WHICH THE PATIENT WANTED THE SCREW TO BE REMOVED. FOR WHICH THE PATIENT UNDERWENT EXPLANT SURGERY ON (B)(6) 2017. THE SET SCREW DID NOT UNSCREW AS BEING COLD WELDED TO THE CONNECTOR AND METAL CUTTING BURS WERE USED TO CUT THE CONSTRUCT TO REMOVE THE ILIAC SCREWS. PATIENT ISSUE HAS BEEN RESOLVED NOW.

  Patient problems: Pain

  MAUDE report 6881815 ↗
• InjuryAug 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT WITH PREOPERATIVE DIAGNOSIS OF NEUROMUSCULAR SCOLIOSIS, PARAPARESIS UNDERWENT FUSION PROCEDURE AT LEVELS TH11-ILIAC. ON UNKNOWN DATE, POST-OP, THE SET SCREW GOT DISCONNECTED FROM THE ILLIAC CONNECTOR.ON (B)(6) 2017 A REVISION SURGERY TOOK PLACE WHERE IT WAS EXPLANTED. THE ROD HAD BEEN SLIPPED OUT AND TRANSLATED FROM SCREWS. NO MALFUNCTION REPORTED WITH ROD. THE SURGEON REPLACED THE COCR RODS WITH TI ALLOY RODS FOR MORE FLEXIBILITY ON PATIENT FUSION. CHANGING BODY POSITION(INCREASED KYPHOSIS) WAS REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Code Available

  MAUDE report 6783893 ↗