CD HORIZON® Spinal System 5531414Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169347816), received between Feb 13, 2017 and Sep 9, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Device Dislodged or Dislocated

  Information was received from a healthcare provider regarding a Patient having revision surgery due to adult spinal deformity. In a repeat surgery case for adult spinal deformity following the initial surgery performed on (b)(6) 2024, hook dislodgement at the upper fixed end was reported for products 5531414 SO56 Transverse Hook Light and 5531415 SO56 Transverse Hook Left, both implanted at thoracic vertebra 4. Patient underwent additional surgery to extend the fixation range upward and re-fix the construct following the reported dislodgement. The patient required hospitalization or extended care after discharging due to pressure ulcer and back pain, developed bedsore and back pain.  Bone fusion was reported as not achieved immediately after surgery. There were no further complications reported.

  Patient problems: Pain; Pressure Sore/Ulcer

  MAUDE report 50686831 ↗
• InjuryJan 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, THE TRANSVERSE PROCESS BROKE OFF. NO DEVICE MALFUNCTION WAS REPORTED. BUT THERE WAS POSSIBILITY THAT THE TRANSVERSE PROCESS BROKE OFF BECAUSE THE HOOK HAVE BEEN ALLEGEDLY PLACED IN THE WRONG DIRECTION BY MISTAKE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8230422 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FUSION AT T9/S2 DUE TO KYPHOSCOLIOSIS DEVELOPED PROXIMAL JUNCTION FAILURE, POST-OP, COMPRESSION FRACTURE OCCURRED AT T9. THE REOPERATION FOR EXTENDING TO T3 WAS PERFORMED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO DEVICE MALFUNCTION WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 7410543 ↗
• InjuryFeb 13, 2017Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT T5-S2AI FIXATION. ON (B)(6) 2018, POST-OP, INFECTION WAS OBSERVED AT HOOK PLACED AT T5. HOOK HAD MIGRATED DUE TO FRACTURE. AS A RESULT OF THE EVENT SOME OF THE IMPLANTS AROUND 'SUPERIOR' THE INFECTED AREA WERE REMOVED AND ROD WAS CUT.

  Patient problems: Bone Fracture(s); No Code Available; Unspecified Infection

  MAUDE report 6325052 ↗