VERTEX® Reconstruction System 6958726Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994354983), received between Mar 4, 2025 and Mar 5, 2025 — classified as 1 injury, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K083071); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM REGULATORY BODY (RB), HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED FOR ROBOT-ASSISTED SKULL TRACTION POSTERIOR CERVICAL APPROACH ATLANTOAXIAL REDUCTION AND INTERNAL FIXATION WAS PERFORMED FOR TREATMENT OF AXIS FRACTURE. IT WAS REPORTED THAT AFTER THE OPERATION, WOUND INFECTION OCCURRED ON (B)(6)2024. DEBRIDEMENT, PERFUSION, FLUSHING AND DRAINAGE OPERATION WAS PERFORMED ON (B)(6)2024. THE CAUSE OF INFECTION WAS DUE TO PATIENT'S CONDITION. THERE WAS NO DEVICE MALFUNCTION REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WAS NO MALFUNCTION WITH REPORTED PRODUCTS AND THEY ARE NOT EXPLANTED, STILL REMAINS IN PATIENT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21524310 ↗
• MalfunctionMar 4, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN OPEN DECOMPRESSION AND INTERNAL FIXATION PROCEDURE IN A PATIENT DIAGNOSED WITH POSTERIOR CERVICAL SPINAL STENOSIS. IT WAS REPORTED THAT THE SCREW THREAD WAS DAMAGED DURING THE SCREWING PROCESS AND COULDN'T BE USED ANY FURTHER. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512509 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083071. One submission often covers many models, so check the product and lot details in each record.

• Z-1826-2016 · Apr 1, 2016 · Terminated
  Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.