CD HORIZON® Spinal System 7578301Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169177048), received between Jan 29, 2018 and Oct 4, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING AN EXTENSION OF FIXATION RANGE FROM L3-L4 TO L2-L5. THE SET CAPS AND ROD WERE REMOVED. SCREWS AT L2 AND L5 WERE PLACED, AND REDUCERS/EXTENDERS WERE USED TO AID WHEN SEATING THE ROD. INTRA-OP, IT WAS OBSERVED THAT ONE OF THE REDUCERS/EXTENDERS COULD NOT STAY RETAINED ON THE TULIP OF THE SCREW. THE PHYSICIAN TRIED A COUPLE OF TIMES BUT THE PRODUCT WOULDN'T STAY. THEN, THE ALLEGED PRODUCT WAS REMOVED IMMEDIATELY FROM USE AND THE STERILE FIELD, AND ANOTHER ONE WAS USED FROM THE TRAY. THERE WERE NO FURTHER ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9155553 ↗
• MalfunctionApr 18, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) WITH POSTERIOR FIXATION. DURING SURGERY, THERE WAS AN AUDIBLE POP SOUND AND THE TOWER CAME OFF. THE SCREW AND THE TOWER AT L5 WERE THEN REPLACED WITH NEW ONES. THEN BOTH THE PERSUADERS WERE REDUCED DOWN TO 4MM. THE S1 SET SCREWS WERE ENGAGED BUT THE L5 SET SCREW WOULD NOT ENGAGE SO PERSUADER WAS REDUCED TO JUST A 1 MM MORE AND THIS IS WHEN THE TOWER POPPED OFF OF THE SCREW AGAIN, BUT JUST ON ONE SIDE. AT THIS POINT, THE L5 SCREW WAS SWITCHED, TLIF WAS COMPLETED AND SCREWS AND A ROD WERE PUT ON THE PATIENTS LEFT SIDE WITH NO FURTHER ISSUES. 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 7439118 ↗
• MalfunctionJan 29, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) WITH POSTERIOR FIXATION. DURING SURGERY, THERE WAS AN AUDIBLE POP SOUND AND THE TOWER CAME OFF. THE SCREW AND THE TOWER AT L5 WERE THEN REPLACED WITH NEW ONES. THEN BOTH THE PERSUADERS WERE REDUCED DOWN TO 4MM. THE S1 SET SCREWS WERE ENGAGED BUT THE L5 SET SCREW WOULD NOT ENGAGE SO PERSUADER WAS REDUCED TO JUST A 1 MM MORE AND THIS IS WHEN THE TOWER POPPED OFF OF THE SCREW AGAIN, BUT JUST ON ONE SIDE. AT THIS POINT, THE L5 SCREW WAS SWITCHED, TLIF WAS COMPLETED AND SCREWS AND A ROD WERE PUT ON THE PATIENTS LEFT SIDE WITH NO FURTHER ISSUES. 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 7224665 ↗