CHESAPEAKE Stabilization System 2008-90051Recalls & reported problems
VB Spine LLC · Universal Drill Size Ø5.5x20 mm · Class 1
All models of CHESAPEAKE Stabilization System (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888857025684), received between Aug 2, 2022 and Jan 14, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (4 reports).
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
- Material Deformation4
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2026Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A CHESAPEAKE ANTERIOR LUMBAR UNIVERSAL DRILL DEFORMED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067509 ↗MalfunctionJan 6, 2026Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT THE TIPS OF TWO CHESAPEAKE ANTERIOR LUMBAR UNIVERSAL AWLS AND THE TIPS OF TWO CHESAPEAKE ANTERIOR LUMBAR UNIVERSAL DRILLS DEFORMED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO DRILLS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23975096 ↗MalfunctionJan 6, 2026Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT THE TIPS OF TWO CHESAPEAKE ANTERIOR LUMBAR UNIVERSAL AWLS AND THE TIPS OF TWO CHESAPEAKE ANTERIOR LUMBAR UNIVERSAL DRILLS DEFORMED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO DRILLS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23975082 ↗MalfunctionSep 9, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A CHESAPEAKE AL UNIVERSAL DRILL FRACTURED OFF INTRA-OPERATIVELY. THE FRACTURED TIP WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH LESS THAN A ONE MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20176356 ↗MalfunctionAug 2, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT TWO (2) CHESAPEAKE UNIVERSAL DRILLS BENT WHILST PREPARING HOLES FOR SCREWS INTRA-OPERATIVELY. THE SURGERY WAS COMPLETED SUCCESSFULLY AND NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE SECOND OF THE TWO DRILLS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15147397 ↗
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- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
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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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