Zero-P 04.617.228SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034742151), received between May 6, 2022 and May 6, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryMay 6, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 AFTER EXPLORATORY SURGERY TO DETERMINE IF A SCREW BACKED OUT OF A ZERO-P STANDALONE DEVICE. IT WAS CONFIRMED THAT THE SCREW HAD BACKED OUT AND THE SCREW WAS THEN REMOVED. ASSESSMENT OF THE OPERATIVE LEVEL CONFIRMED ADEQUATE FUSION WAS TAKING PLACE SO THE REMAINING CONSTRUCT WAS LEFT INTACT. THE ORIGINAL SURGERY WAS ON (B)(6) 2022. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) ZERO-P IMPLANT 8MM HEIGHT LORDOTIC/LARGE-STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14309238 ↗