CD HORIZON® Spinal System 7575300Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885074445380), received between Oct 31, 2018 and May 19, 2026 — classified as 9 malfunctions.

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

• MalfunctionMay 19, 2026Break

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE MATERIAL WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25225623 ↗
• MalfunctionApr 1, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A ROD INSERTER. IT WAS REPORTED THAT ROD WAS NOT FIXED. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756654 ↗
• MalfunctionMar 13, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE ROD WAS NOT ABLE TO BE FIXED WITH INSERTER. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590154 ↗
• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE ROD INSERTER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THIS PRODUCT BROKE AT SOME POINT AND WAS MISSING A SCREW/POST. IT WORKED FINE PREVIOUS TO THAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567856 ↗
• MalfunctionDec 27, 2019Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MINIMALLY INVASIVE LUMBAR FUSION. INTRA-OP, THE ROD DISLODGED FROM THE INSERTER DURING THE SURGERY BEFORE THE SURGEON WAS READY TO TAKE IT OFF. THIS LED TO THE SURGEON REMOVING THE SCREWS AND RE-IMPLANTING THE SCREWS AND RODS. IT IS UNKNOWN WHETHER THERE WERE ANY PATIENT COMPLICATIONS DUE TO THIS EVENT.

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

  MAUDE report 9527674 ↗
• MalfunctionDec 21, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-L5. INTRA-OP, AFTER LOCKING THE ROD ON THE IMPLANT HOLDER, THE ROD AT THE END OF THE INSERTER (THAT PULLS THE ROD TO LOCK) BROKE. THE BREAKAGE WAS UNDER THE LOCK KEY. NO FRAGMENT OF THE BROKEN INSTRUMENT WAS FOUND TO BE PRESENT INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9508542 ↗
• MalfunctionJul 5, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS- DISC HERNIA LUMBAR L5-S1 PROCEDURE- TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) LEVELS IMPLANTED- L5-S1 IT WAS REPORTED THAT INTRA-OP, THE TALE OF THE INSTRUMENT WAS BROKEN DURING THE SURGERY. NO ANY FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8763663 ↗
• MalfunctionOct 31, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL STENOSIS AND UNDERWENT FUSION SURGERY AT L5-S1. DURING THE SURGERY, THE ROD DISLODGED FROM THE ROD INSERTER AND WAS RETRIEVED AND REATTACHED ON THE INSERTER. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS OCCURRED IN THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8026741 ↗
• MalfunctionOct 31, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL STENOSIS ANA UNDERWENT FUSION SURGERY AT L5-S1. DURING THE SURGERY, THE ROD DISLODGED FROM THE ROD INSERTER AND WAS RETRIEVED AND REATTACHED ON THE INSERTER.THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS OCCURRED IN THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8026740 ↗