NA 03.161.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034711553), received between Apr 19, 2023 and Apr 19, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT SEVERAL DEVICES WERE RECEIVED AS BLIND UNITS ON (B)(6) 2023. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT A TRIAL ROD HAD SIGNS OF HEAVY SCRATCHES AND DISCOLORATION OF THE BLUE ANODIZE. ADDITIONALLY, HE ROD WAS BROKEN BETWEEN THE THIRD AND FOURTH SCREW HOLES. THIS REPORT IS FOR A TEMPLATE FOR OCCIPITAL PLATE/ROD. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769721 ↗