CAYMAN Plate System-MIRecalls & reported problems across all models
VB Spine LLC · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 11 models of CAYMAN Plate System-MI by VB Spine LLC in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Oct 13, 2015 and Jul 6, 2026 — classified as 1 injury, 35 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CAYMAN Plate System-MI problems
Device problems
- Material Deformation18
- Fracture14
- Difficult to Insert4
- Break2
- Migration2
- Mechanical Problem1
- Migration or Expulsion of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Foreign Body In Patient1
- No Code Available1
- No Consequences Or Impact To Patient1
- No Information1
CAYMAN Plate System-MI models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CAYMAN Plate System-MI 4508-90075Orthopedic manual surgical instrument17 reports
- CAYMAN Plate System-MI 4508-90143Orthopedic manual surgical instrument5 reports
- CAYMAN® Plate System-MI 4501-15040APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- CAYMAN® Plate System-MI 4501-15036APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- CAYMAN® Plate System-MI 4501-15048APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- CAYMAN® Plate System-MI 4501-15028APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- CAYMAN® Plate System-MI 4501-15032APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- CAYMAN® Plate System-MI 4508-41F14APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- CAYMAN Plate System-MI 4508-90011Orthopedic manual surgical instrument1 report
- CAYMAN Plate System-MI 4508-90076Orthopedic manual surgical instrument1 report
- CAYMAN® Plate System-MI SP-4224Intervertebral fusion device with bone graft, lumbar1 report
Recent CAYMAN Plate System-MI adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 6, 2026Difficult to Insert
A COMPANY REPRESENTATIVE REPORTED THAT A CAYMAN UNITED PLATE INSERTER WAS DIFFICULT TO ASSEMBLE WITH A PLATE 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 25727953 ↗MalfunctionJun 2, 2026Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A CAYMAN SPRING LOADED AWL 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 25365338 ↗MalfunctionMay 1, 2026Fracture; Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT A CAYMAN MI DRILL AND A CAYMAN MI AWL "BROKE" INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE DRILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055718 ↗MalfunctionMay 1, 2026Fracture; Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT A CAYMAN MI DRILL AND A CAYMAN MI AWL "BROKE" INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE AWL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055692 ↗MalfunctionFeb 26, 2026Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24464786 ↗MalfunctionFeb 11, 2026Material Deformation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24319251 ↗MalfunctionJan 8, 2026Difficult to Insert
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24005284 ↗MalfunctionJan 8, 2026Difficult to Insert
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24005282 ↗MalfunctionJan 8, 2026Difficult to Insert
A HEALTH PROFESSIONAL REPORTED THAT TWO CAYMAN MI SELF-STARTING SCREWS PASSED THROUGH A CAYMAN MI LATERAL PLATE DURING FINAL LOCKING INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30-MINUTE SURGICAL DELAY BY USING REPLACEMENT SCREWS AND A LARGER PLATE. THIS REPORT CAPTURES THE PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24005281 ↗MalfunctionJan 6, 2026Material Deformation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23975098 ↗MalfunctionOct 21, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348978 ↗MalfunctionJul 23, 2025Material Deformation; Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A CAYMAN MI SPRING LOADED AWL 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 22580137 ↗MalfunctionApr 17, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21862322 ↗MalfunctionJan 8, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A CAYMAN MI INNER THREADED FLEX SHAFT FRACTURED INTRA-OPERATIVELY, AND THAT THE FRACTURED COMPONENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21101289 ↗MalfunctionOct 16, 2024Material Deformation; Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT A CAYMAN SPRING LOADED AWL DEFORMED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20467458 ↗
Other VB Spine LLC products
- EVEREST Spinal System77 models · 336 reports · 3 recalls
- YUKON OCT Spinal System54 models · 238 reports · 3 recalls
- OZARK Cervical Plate System54 models · 270 reports
- MESA Spinal System55 models · 140 reports
- ALEUTIAN Interbody Systems37 models · 135 reports
- CHESAPEAKE Stabilization System31 models · 46 reports · 1 recall
- PYRENEES Cervical Plate System29 models · 96 reports
- DENALI Spinal System22 models · 80 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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