CHESAPEAKE Stabilization System 3608-90030Recalls & reported problems
VB Spine LLC · 3-Screw Drill Guide Inserter Size 7 mm · Class 1
All models of CHESAPEAKE Stabilization System (31)
Data updated Oct 16, 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 10888857082540), received between Aug 8, 2022 and Feb 10, 2025 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Mechanical Problem1
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.
MalfunctionFeb 10, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21349259 ↗MalfunctionAug 8, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THREE (3) CHESAPEAKE CERVICAL TI 3-SCREW DRILL GUIDE INSERTERS COULD NO LONGER HOLD IMPLANTS INTRA-OPERATIVELY. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT CAPTURES THE FIRST OF THREE DRILL GUIDE INSERTERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15186107 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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