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CHESAPEAKE® Stabilization System 2001-15525Recalls & reported problems

VB Spine LLC · Screw Size Ø5.5x25 mm · Class 2 · Implant

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 10888857025417), received between Mar 2, 2022 and Mar 2, 2022 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Mechanical Problem1
  • Unintended Ejection1

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.

  • MalfunctionMar 2, 2022Unintended Ejection; Mechanical Problem; Unintended Ejection; Mechanical Problem

    IT WAS REPORTED THAT DURING A CHESAPEAKE LUMBER CASE, THE UNIVERSAL AWL 'SKIVED' OFF THE ENDPLATE AND DID NOT CREATE THE NECESSARY PILOT HOLE FOR THE SCREW. THIS RESULTED IN THE CAGES AT S1 AND L4 HAVING ONLY 2 SCREWS INSERTED INSTEAD OF 3. ADDITIONALLY, DURING SCREW INSERTION, THE ANGLED TAPERED DRIVER CAME OFF OF THE SCREW. IT WAS ALSO OBSERVED THAT THE LASER MARKINGS HAD WORN OFF OF THE EXPANDABLE DRILL GUIDE. THIS REPORT WILL CAPTURE THE SCREW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13655680 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.