Centerpiece Plate Fixation System G8532067Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000553470), received between Dec 29, 2025 and Mar 2, 2026 — classified as 3 malfunctions.

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

• MalfunctionMar 2, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A C3, C4, C5, C6 LAMINOPLASTY PROCEDURE FOR CERVICAL SPINAL COMPRESSION. IT WAS REPORTED THAT UPON HAND TIGHTENING THE SCREW, THE 2 SCREWS BROKE LEAVING THE HEAD PART OF THE SCREW OUT AND THE REMAINING PART OF THE SCREW INSIDE THE PATIENT. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482455 ↗
• MalfunctionMar 2, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A C3, C4, C5, C6 LAMINOPLASTY PROCEDURE FOR CERVICAL SPINAL COMPRESSION. IT WAS REPORTED THAT UPON HAND TIGHTENING THE SCREW, THE 2 SCREWS BROKE LEAVING THE HEAD PART OF THE SCREW OUT AND THE REMAINING PART OF THE SCREW INSIDE THE PATIENT. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482448 ↗
• MalfunctionDec 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR LAMINOPLASTY. IT WAS REPORTED THAT THE HEAD OF A BONE SCREW BROKE DURING INTRODUCTION, RESULTING IN THE SCREW BODY REMAINING IN THE PATIENT AS A RETAINED IMPLANT FRAGMENT. IT WAS CONFIRMED THAT THE PRODUCT WAS UTILIZED ACCORDING TO THE DIRECTIONS FOR USE. NO TREATMENT OR ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE IS NO REVISION SURGERY SCHEDULED OR PLANNED FOR THE REMOVAL OF BROKEN FRAGMENTS FROM PATIENT. THIS EVENT HAS BEEN OCCURRED DUE TO POTENTIAL MANUFACTURING ISSUE OF THE DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23905444 ↗