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CHESAPEAKE® Stabilization System 3601-13816Recalls & reported problems

VB Spine LLC · Screw, Self-Tapping Size Ø3.85x16 mm · Class 2 · Implant

All models of CHESAPEAKE Stabilization System (31)

Data updated Oct 18, 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 10888857081154), received between Apr 22, 2022 and Apr 22, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

Device problems

  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionApr 22, 2022Material Deformation; Material Deformation

    IT WAS REPORTED THAT A CHESAPEAKE SCREW GOT 'NIPPED' IN ITS DISTAL THREADS INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14187360 ↗

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Sources and updates

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