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CHESAPEAKE® Stabilization System 2013-21530L10Recalls & reported problems

VB Spine LLC · Implant · Class 2 · Implant

All models of CHESAPEAKE Stabilization System (31)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857027862), received between Mar 2, 2022 and Mar 2, 2022 — classified as 2 malfunctions.

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

  • Misassembled1
  • Misassembled During Installation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 2, 2022Misassembled; Misassembled

    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 FIRST OF TWO CAGES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13655343 ↗
  • MalfunctionMar 2, 2022Misassembled During Installation; Misassembled During Installation

    A COMPANY REPRESENTATIVE REPORTED THAT THE CHESAPEAKE EXPANDABLE DRILL GUIDE DISENGAGED FROM THE IMPLANT DURING SURGERY WHILE THE SURGEON WAS PREPARING A PILOT HOLE FOR THE SECOND SCREW. THE DRILL GUIDE WAS NOT REATTACHED AND THE SECOND SCREW WAS INSERTED FREEHAND INTO THE PARTIALLY PREPARED HOLE. THE THIRD SCREW WAS NOT IMPLANTED. THE CHESAPEAKE ANTERIOR LUMBAR IMPLANT WAS PLACED WITH ONLY TWO OF THE THREE SCREWS SO THAT THE DEVICE WAS ONLY INSTRUMENTED TO A SINGLE ADJACENT VERTEBRAL BODY. THIS REPORT CAPTURES THE CHESAPEAKE ANTERIOR LUMBAR IMPLANT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13654467 ↗

Other Intervertebral fusion device with integrated fixation, lumbar devices

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Sources and updates

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