VERTEX® Reconstruction System 6958734Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994354945), received between Mar 12, 2019 and Mar 12, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjuryMar 12, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: SCOLIOSIS TYPE OF PROCEDURE OR TECHNIQUE USED: DEROTATION AND STABILIZATION OF THE SCOLIOSIS IT WAS REPORTED THAT, POST-OP, VERTEX SCREW BROKE INSIDE THE PATIENT. A REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN SCREW FROM THE CONVEX SIDE BUT THE TIP OF SCREW COULD NOT BE REMOVED. THE FRAGMENT REMAINS INSIDE THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8411470 ↗

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.