NA 04.617.816.02SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705034742301), received between Apr 30, 2020 and Apr 30, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 30, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TITANIUM CERVICAL SPINE LOCKING SCREWS WERE UNABLE TO LOCK INTO THE PLATE. THERE WERE 2 SCREWS THAT WOULD NOT LOCK. A NEW PACK OF SCREWS WAS OPENED AND THE 2 NEW SCREWS WERE IMPLANTED AND LOCKED WITH NO ISSUES. THERE WAS NO ISSUE WITH THE ZERO-P PLATE JUST THE 2 SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES: UNKNOWN CAGE/PLATE (PART#UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN SCREWS: ZERO-P VA (PART#UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR 1 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10015144 ↗