N/A 8530810Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074540979), received between Jan 9, 2024 and Jan 9, 2024 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING SCREWS AND PLATES WITH SPINAL THERAPY. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO ENLARGE THE VERTEBRAL ARCH DURING THE TRIAL, HOWEVER, THE VERTEBRAL ARCH WAS PARTIALLY TRANSECTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT PATIENT HAD REPORTED DISSECTION OF THE VERTEBRAL ARCH. PRE-OP DIAGNOSIS FOR THE PATIENT WAS CERVICAL SPONDYLOSIS RAW MYELOPATHY. PROCEDURE INVOLVED IN THIS EVENT WAS CERVICAL LAMINOPLASTY. THERE WAS NO REVISION SURGERY PLANNED/ OCCURRED AS A RESULT OF THE EVENT. PATIENT HAD FRACTURED VERTEBRAL ARCH DURING USE OF TRIAL AT UPPER C4-C5. THERE WAS NO FAILURE OF THE TRIAL ITSELF AND THERE WERE NO DEFECTS IN THE REPORTED PRODUCTS. LAMINECTOMY WAS PERFORMED AND THE WOUND WAS CLOSED.

  Patient problems: Bone Fracture(s)

  MAUDE report 18473591 ↗