CHESAPEAKE Stabilization System 2008-90025Recalls & reported problems
VB Spine LLC · Universal Awl Size 20 mm · Class 1
All models of CHESAPEAKE Stabilization System (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888857025509), received between Feb 25, 2022 and Jan 6, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (6 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 Deformation6
- Material Separation1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2026Material Deformation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23975097 ↗MalfunctionJan 6, 2026Material Deformation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23975094 ↗MalfunctionDec 19, 2025Material Deformation; Material Deformation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23855433 ↗MalfunctionDec 19, 2025Material Deformation; Material Deformation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23855432 ↗MalfunctionMay 17, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT A CHESAPEAKE ANTERIOR LUMBAR AWL WAS BENT OUTSIDE THE OPERATING ROOM. THERE WAS NO ASSOCIATED PROCEDURE WITH THIS EVENT, THEREFORE, NO ADVERSE CONSEQUENCES TO ANY PATIENTS WERE SEEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14415870 ↗MalfunctionMar 2, 2022Mechanical Problem; Material Separation; Mechanical Problem; Material Separation
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 UNIVERSAL AWL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13655327 ↗MalfunctionFeb 25, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TIP OF A CHESAPEAKE UNIVERSAL AWL WAS BENT OUTSIDE OF THE OR. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13600686 ↗
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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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