BASE 6955172Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517802736), received between Mar 1, 2018 and Oct 17, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

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

• InjuryOct 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 PATIENT UNDERWENT A SPINAL PROCEDURE. AS PER REPORTER, POST OPERATIVELY IT WAS REPORTED LATERAL MASS INFUSION WAS INCOMPLETE. ON (B)(6) 2019 A REVISION PROCEDURE WAS PERFORMED AT L4/5 LEVELS.

  Patient problems: No Code Available

  MAUDE report 10694617 ↗
• InjuryMar 1, 2018Unintended Movement; Unintended Movement

  ON (B)(6) 2018 A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION AT L5/S1 LEVELS WITH DISC ARTHROPLASTY AT L4/L5 WITHOUT ANY REPORTED ISSUES. AS PER REPORTER PATIENT WOKE UP WITH ALLEVIATED SYMPTOMS AND RADIOGRAPHS WERE CLEAR. ON (B)(6) 2018 PATIENT RECEIVED POSTERIOR FIXATION AT L5/S1 UTILIZING ANOTHER MANUFACTURER'S HARDWARE AND NAVIGATION. PATIENT AWOKE IN PAIN, A POST-OPERATIVE CT SCAN IDENTIFIED A SPINAL CANAL BREACH AT L5 LEVEL BY ONE OF THE SUPERIOR INTERFIXATED SCREWS. AN IMMEDIATE ANTERIOR PROCEDURE WAS PERFORMED TO REMOVE THE IMPENDING SCREW LEAVING ONE SUPERIOR AND ONE INFERIOR SCREW. PATIENT NOTED AS DOING WELL POST REVISION PROCEDURE. NO ALLEGATION OF PRODUCT MALFUNCTION RELATED TO NUVASIVE PRODUCTS.

  Patient problems: Pain

  MAUDE report 7306930 ↗