CAYMAN® Plate System-MI 4501-15040Recalls & reported problems
VB Spine LLC · Screw, Self Starting Size Ø5.0x40 mm · Class 2 · Implant
All models of CAYMAN Plate System-MI (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888857093119), received between Aug 15, 2022 and Jun 18, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Break1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A CAYMAN UNITED SELF-STARTING SCREW FRACTURED DURING INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19564252 ↗MalfunctionDec 6, 2023Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-OPERATIVELY A CAYMAN SELF-STARTING SCREW MIGRATED. REVISION SURGERY HAS NOT BEEN PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18277116 ↗MalfunctionSep 14, 2022Fracture; Fracture
A USER REPORTED THAT A CAYMAN MI SELF-STARTING SCREW FRACTURED DURING IMPLANTATION. THE SURGEON LEFT THE SCREW IN PLACE AND SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO REPORTED SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15417949 ↗MalfunctionAug 15, 2022Break
SCREW BROKE DURING INSERTION. CLINICAL DECISION WAS MADE TO LEAVE THE SCREW INSERTED.
Patient problems: Foreign Body In Patient
MAUDE report 15223758 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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