CD HORIZON® Spinal System 7570855Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885074030241), received between Dec 22, 2016 and Jul 27, 2022 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF FOR AN IND ICATION OF LUMBAR DISC HERNIATION. IT WAS REPORTED THAT WHEN THE SCREW PLUG WAS SCREWED IN, IT WAS SLIPPED. 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 15109517 ↗
• MalfunctionJul 26, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR, HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR LUMBAR DISC HERNIATION. PROCEDURE OR THERAPY PERFORMED WAS TLIF. IT WAS REPORTED THAT THE PRODUCT WAS SLIPPED. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15101345 ↗
• MalfunctionJul 26, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR, HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR LUMBAR DISC HERNIATION. PROCEDURE OR TECHNIQUE USED WAS MIS-TILF. IT WAS REPORTED THAT THE PRODUCT WAS SLIPPED. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15101295 ↗
• MalfunctionJul 22, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING AN WHICH OC CURRED DURING A TLIF PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE PRODUCT SLIPPED INTRA-OPERATIVELY. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15081769 ↗
• MalfunctionJul 20, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP), DISTRIBUTOR VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE SCREW SLIPPED. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCT CAME INTO CONTACT WITH THE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15063299 ↗
• MalfunctionJul 20, 2022Device Slipped; Device Slipped

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT H AVING SPINAL THERAPY FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT SCREW SLIPPED DURING SURGERY. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15062773 ↗
• MalfunctionMay 19, 2020Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR POSTERIOR TRANSDERMAL FIXATION SURGERY DUE TO LUMBAR SPONDYLOLISTHESIS. INTRA-OP, DURING THE SEXTANII SURGERY, THE SCREW PLUG SLIPPED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10068451 ↗
• MalfunctionSep 6, 2019Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR VERTEBRAL DISC HERNIATION; AND UNDERWENT LUMBAR POSTERIOR MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION. INTRA-OP, THE SET SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8968732 ↗
• MalfunctionJul 31, 2018Device Slipped; Failure to Align; Failure to Align

  PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PROTRUSION OF LUMBAR INTER-VERTEBRAL DISC. INTRA-OP, THE SET SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7735677 ↗
• MalfunctionJun 1, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT 'PERCUTANEOUS NAIL' SURGERY DUE TO LUMBAR DISC PROTRUSION. INTRA-OP, THE SET SCREW SLIPPED. THE DEVICE 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

  MAUDE report 7559931 ↗
• MalfunctionMar 7, 2018Failure to Align; Failure to Align

  PRE-OPERATIVE DIAGNOSIS: LUMBAR "OLISTHE" (SPINAL STENOSIS). IT WAS REPORTED THAT INTRA-OP, THE SET SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT BUT WAS REMOVED DURING SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7319620 ↗
• MalfunctionDec 7, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION(OLIF), SPINAL CANAL DECOMPRESSION AND ENDOGRAFT FIXATION ON DUE TO LUMBAR SPINAL STENOSIS. DURING THE SURGERY, THE SCREW PLUG WAS FOUND TO BE ROUGH(NOT SMOOTH) BY THE REPRESENTATIVE. DUE TO INSUFFICIENT LOCKING, THE SCREWS WERE EXPLANTED COMPLETELY. NO PRODUCT BREAKAGES OR THREAD DAMAGE FOR THE SCREWS WERE REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7094727 ↗
• MalfunctionDec 7, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION(OLIF), SPINAL CANAL DECOMPRESSION AND ENDOGRAFT FIXATION ON DUE TO LUMBAR SPINAL STENOSIS. DURING THE SURGERY, THE SCREW PLUG WAS FOUND TO BE ROUGH (NOT SMOOTH) BY THE REPRESENTATIVE. DUE TO INSUFFICIENT LOCKING, THE SCREWS WERE EXPLANTED COMPLETELY. NO PRODUCT BREAKAGES OR THREAD DAMAGE FOR THE SCREWS WERE REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7094686 ↗
• MalfunctionNov 13, 2017Break; Break

  PRE-OP DIAGNOSIS: DISC HERNIATION IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO COMPLETE INTERNAL FIXATION. DURING SURGERY, THE THREAD OF THE SCREW WAS FOUND BROKEN. THE DEVICE BROKE BUT NO FRAGMENT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7026422 ↗
• MalfunctionNov 13, 2017Break; Break

  PRE-OP DIAGNOSIS: DISC HERNIATION IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO COMPLETE INTERNAL FIXATION. DURING SURGERY, THE THREAD OF THE SCREW WAS FOUND BROKEN. THE DEVICE BROKE BUT NO FRAGMENT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7026397 ↗
• MalfunctionDec 22, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED PATIENT UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE IN WHICH PRODUCT WAS FOUND DAMAGED. PHYSICIAN HAD TO REPLACE IT WITH NEW ONE TO COMPLETE THE SURGERY SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6197504 ↗