CAYMAN Plate System-MI 4508-90075Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10888857095526), received between Aug 5, 2021 and Jun 2, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (15 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionFeb 11, 2026Material Deformation

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319251 ↗
• MalfunctionJan 6, 2026Material Deformation

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975098 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 16, 2024Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A CAYMAN MI SPRING LOADED AWL WAS "BROKEN" INTRA-OPERATIVELY. INSPECTION OF THE RETURNED DEVICE INDICATES THAT THE DEVICE TIP WAS DEFORMED. 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 20233638 ↗
• MalfunctionAug 23, 2024Material 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 20050150 ↗
• MalfunctionJun 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE TIP OF A CAYMAN ANGLED LATERAL INSERTER WAS NOT HOLDING A CAYMAN PLATE SECURELY AND THE SPRING OF A CAYMAN SPRING LOADED AWL SPRUNG OUT AND EXTENDED LONGER THAN NECESSARY, POTENTIALLY BREAKING THE PLATE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 10 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE CAYMAN SPRING LOADED AWL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521725 ↗
• MalfunctionOct 29, 2022Material Deformation; Material Deformation

  THIS RECORD IS A CONSOLIDATION OF Q3 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF INTRAOPERATIVE CAYMAN SPRING LOADED AWL TIP DEFORMATION. THE ASSOCIATED 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 15695067 ↗
• MalfunctionJul 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT OUTSIDE OF THE OPERATING ROOM A CAYMAN MI SPRING LOADED AWL WAS NOTICED TO BE SLIGHTLY BENT FROM BEING USED AND NEEDS TO BE REPLACED. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15019072 ↗
• MalfunctionApr 29, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE CAYMAN AWLS WERE BENT INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE THIRD AWL..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255776 ↗
• MalfunctionApr 29, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE CAYMAN AWLS WERE BENT INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE SECOND AWL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255475 ↗
• MalfunctionApr 29, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE CAYMAN AWLS WERE BENT INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE FIRST AWL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255474 ↗
• MalfunctionMar 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIP OF A CAYMAN MI SPRING LOADED AWL WAS 'CURVED' INTRA-OPERATIVELY. 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 13806455 ↗
• MalfunctionDec 3, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE CAYMAN UNITED AWL BROKE INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12929099 ↗
• MalfunctionSep 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIP OF THE CAYMAN MI SPRING LOADED AWL BENT INTRA-OPERATIVELY. THE AWL IS USED TO PREPARE THE BONE FOR PLACEMENT OF SCREWS. THE SURGEON DID NOT ELECT TO USE OR DID NOT HAVE ON HAND A BACK-UP INSTRUMENT TO PREPARE THE SECOND SCREW HOLE. THE CAYMAN UNITED TWO-HOLE PLATE AND CASCADIA INTERBODY WERE IMPLANTED BUT ONLY ONE OF TWO SECURING SCREWS WAS PLACED. NO ADVERSE CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED AND THE SURGEON DOES NOT PLAN TO RE-OPERATE AT THIS TIME. THIS RECORD CAPTURES THE DEFORMED CAYMAN MI SPRING LOADED AWL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558290 ↗
• MalfunctionAug 5, 2021Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  IT WAS REPORTED THAT A HINGE OF CAYMAN MI SPRING LOADED AWL IS 'BROKEN' AND TIP IS BENT INTRA-OPERATIVELY. PIECE WAS RECOVERED FROM PATIENT. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED.  THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284914 ↗