ZERO-P NATURAL 04.617.707SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034811673), received between Mar 8, 2021 and Apr 3, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Mechanical 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION SURGERY. FOLLOWED BY AN INCISION AND DRAINAGE PROCEDURE ON (B)(6) 2024. THE SURGERY RESULTED IN A CARBAPENEM-RESISTANT PSEUDOMONAS AERUGINOSA SPINAL INFECTION, OSTEOMYELITIS, ABSCESS FORMATION, PHLEGMON WITH NERVE ROOT INVOLVEMENT, ACUTE KIDNEY INJURY, BILATERAL LUNG COLLAPSE, AND ADDITIONAL INJURIES.

  Patient problems: Abscess; Bacterial Infection; Nerve Damage; Renal Impairment; Unspecified Infection

  MAUDE report 24781930 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION SURGERY. FOLLOWED BY AN INCISION AND DRAINAGE PROCEDURE ON (B)(6) 2024. THE SURGERY RESULTED IN A CARBAPENEM-RESISTANT PSEUDOMONAS AERUGINOSA SPINAL INFECTION, OSTEOMYELITIS, ABSCESS FORMATION, PHLEGMON WITH NERVE ROOT INVOLVEMENT, ACUTE KIDNEY INJURY, BILATERAL LUNG COLLAPSE, AND ADDITIONAL INJURIES.

  Patient problems: Abscess; Bacterial Infection; Nerve Damage; Renal Impairment; Unspecified Infection

  MAUDE report 24778013 ↗
• InjuryMar 8, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON NEEDED TO DO A REVISION OF A C3-5 ANTERIOR CERVICAL DISCECTOMY AND FUSION DUE TO A C5 NERVE PALSY THAT THE PATIENT PRESENTED WITH POST OP FROM HIS ORIGINAL SURGERY FOUR WEEKS PRIOR. THE ORIGINAL SURGERY WAS COMPLETED AT (B)(6) HOSPITAL ON (B)(6) 2021. THE PATIENT SUFFERED A FALL IN THE BATHTUB AND UPON FURTHER CT DIAGNOSTIC IMAGING, IT APPEARED THAT THE SCREWS FROM THE ZERO-P NATURAL PLATE PULLED OUT OF C4 AND WERE FLOATING ANTERIOR TO AN ADJACENT VECTRA PLATE. THE SURGEON REMOVED THE FLOATING SCREWS AND ALL EXISTING HARDWARE TO ASSESS THE C5 NERVE PALSY THEN REINSTRUMENTED FROM C3-5 WITH NEW HARDWARE. THE SCREWS FROM THE ZERO-P NATURAL PLATE LOOSENED FROM THE PLATE POSTOPERATIVELY. IT IS UNKNOWN IF THERE IS SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) ZERO-P NATURAL PLATE SIZE 7 WITH ASSEMBLY TOOL-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11437178 ↗