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Spider Cervical Plating System N60000137Recalls & reported problems

Xtant Medical Holdings, Inc. · 4mm x 16mm Screw (Variable) · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697N600001371), received between Feb 21, 2020 and Feb 21, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

Device problems

  • Fracture1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 21, 2020Fracture; Fracture

    A COMPLAINANT COMMUNICATED TO THE COMPANY ON (B)(6) 2020 THAT A FRACTURED IMPLANT SCREW WAS IDENTIFIED BY X-RAY PRIOR TO PERFORMING A REVISION PROCEDURE ON (B)(6) 2020. THE FRACTURED SCREW POSED NO PROBLEMS TO THE PATIENT AND WAS NOT THE REASON FOR REVISION. THE REVISION PROCEDURE WAS BEING PERFORMED DUE TO NON-FUSION AND ADJACENT LEVEL SYNDROME, WHICH ADDED HARDWARE TO THE ADJACENT LEVEL AND WAS BACKED UP POSTERIORLY. THE COMPLAINANT RETURNED THE FRACTURED SCREW TO THE COMPANY ON (B)(6) 2020.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9739912 ↗

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Sources and updates

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