VERTEX® Reconstruction System 7751101Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994460097), received between Aug 14, 2018 and Aug 14, 2018 — 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS: PSEUDO REPAIR FOR FAILED HARDWARE C2-C7 POSTERIOR CERVICAL FUSION PROCEDURE: ORIGINAL POSTERIOR CERVICAL FUSION FROM C2-C7 WAS PERFORMED APPROXIMATELY 2 YEARS AGO. POSTED SCREWS WERE PLACED IN C2 WITH SMALL CONNECTORS. AT FIRST POST OP FOLLOW UP (6 WEEKS) THE CONNECTOR HAD FAILED AND BROKE IN THE PATIENT. IT WAS REPORTED THAT THE PRODUCT WAS IMPLANTED ROUGHLY 2 YEARS AGO. POST-OP, THE CONNECTOR HAD FAILED AND BROKE IN THE PATIENT. SOLID FUSION WAS NOT ACHIEVED. ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF THE EVENT FOR REMOVAL.

  Patient problems: Failure of Implant

  MAUDE report 7780867 ↗

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.