NEOSYS G02 10191Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03701337606275), received between Jan 29, 2026 and Jan 29, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 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.

• MalfunctionJan 29, 2026Use of Device Problem; Insufficient Device Problem Information

  BASED ON THE INFORMATION PROVIDED BY THE USER, THE TIP OF THE SINGLE [?] USE SCREWDRIVER FRACTURED DURING SCREW INSERTION. THE FRAGMENTS FELL INTO THE SURGICAL SITE AND WERE RETRIEVED, AND NO PATIENT HARM HAS BEEN REPORTED. THE DEVICE INVOLVED WILL NOT BE RETURNED TO THE MANUFACTURER, PREVENTING A PHYSICAL EXAMINATION OF THE PRODUCT. AS PART OF THE MANUFACTURER'S INVESTIGATION, THE BATCH DOCUMENTATION WILL BE REVIEWED TO IDENTIFY ANY POTENTIAL ANOMALIES. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE ROOT CAUSE CANNOT BE DETERMINED AT THIS STAGE AND THE ASSESSMENT REMAINS ONGOING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207183 ↗