VERTEX® Reconstruction System 7753520Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994448767), received between Jun 26, 2018 and Jun 26, 2018 — classified as 1 malfunction.

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 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.

• MalfunctionJun 26, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH C3-5 TUMOR, KYPHOSIS, FORAMINAL STENOSIS AND UNDERWENT POSTERIOR CERVICAL FUSION SURGERY. DURING SURGERY, THE LOCKING SCREW FOR THE CONNECTOR SHEARED OFF. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE IMPLANT WERE REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7636647 ↗

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.