CHESAPEAKE® Stabilization System 2001-15530Recalls & reported problems
VB Spine LLC · Screw Size Ø5.5x30 mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857025424), received between Apr 28, 2017 and Jun 9, 2023 — classified as 1 injury, 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture1
- Migration or Expulsion of Device1
Patient problems
- No Information1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2023Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A CHESAPEAKE SCREW FRACTURED APPROXIMATELY 2 YEARS AFTER IMPLANTATION. THE PATIENT REPORTED EXPERIENCING PAIN AND SHOWED SIGNS OF PSEUDO ARTHROSIS. REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED.
Patient problems: Pain
MAUDE report 17097525 ↗MalfunctionApr 28, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A SCREW BACK-OUT. THE PATIENT REPORTEDLY HAD A SCREW BACK-OUT APPROXIMATELY 4 MONTHS POST-OP. THERE ARE NO PLANS TO REVISE AT THIS TIME. THE PATIENT IS ASYMPTOMATIC.
Patient problems: No Information
MAUDE report 6530268 ↗
Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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