CORAIL L20432Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295258223), received between Jul 21, 2017 and Feb 29, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK SEGMENT IS JAMMED AND IMPOSSIBLE TO PUT ON MATING DEVICE, , WHICH MADE SURGERY DIFFICULT AND LENGTHENED THE OPERATING TIME WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED:UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST: TRUE.

  Patient problems: Insufficient Information

  MAUDE report 18808578 ↗
• MalfunctionDec 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT NECK TRIAL GOT STUCK ON BROACH. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367033 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT THE HEAD TRIAL LOCKING RING CAME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18143919 ↗
• MalfunctionJul 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK TRIALS WOULD NOT FIT DOWN ON THE BROACH. THE CALCAR PLANE WAS ALSO REPORTED TO BE BLUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398932 ↗
• MalfunctionFeb 17, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE INSTRUMENTS ARE BLUNT AND NEEDED TO BE UPGRADED. THERE WAS NO DELAY IN SURGERY. IT WAS REPORT TODAY (2ND FEBRUARY 2023) THE HEADS ARE ALL SCRATCHED AND DAMAGED AND THE SURGEON HAS COMPLAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396558 ↗
• MalfunctionJan 4, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  WOULDN¿T CONNECT TO BROACH CORRECTLY DURING TRIAL, RETRIEVED FROM PATIENT IN ONE PIECE NO ADVERSE AFFECTS ON PATIENT OR OPERATION. THE HOSPITAL HAS NOT REQUESTED ANY FURTHER INVESTIGATION OR FOLLOW UP AND IS REPORTING IN ORDER TO RECEIVE A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095422 ↗
• MalfunctionJul 12, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENTS WERE WORN ¿ ALL BEEN IN SERVICE CIRCA 10 YEARS AND HAVE WORN. NO IMPACT ON PATIENT. NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12154809 ↗
• MalfunctionDec 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE KLA NECK SEGMENT WOULD NOT FULLY SEAT. NO ADDITIONAL INFORMATION AVAILABLE. NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11057030 ↗
• MalfunctionOct 23, 2020Break; Crack; Physical Resistance/Sticking; Break; Crack; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RUBBER RING IN THE NECK TRIAL WAS CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10730561 ↗
• MalfunctionJan 2, 2020Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CORAIL SIZE 12 BROACH STRUGGLED TO GET INTO BROACH HANDLE. THEN WE HAD A HARD TIME DISENGAGING THE KLA TRIAL NECK FROM THE SIZE 12 BROACH AFTER TRIALING. THERE WAS FIVE MINUTES SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 9538592 ↗
• MalfunctionApr 5, 2019Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE RING AROUND CORAIL KLA NECK TRIAL CAME OFF. X-RAY WAS PRESENT DURING CASE, NO PIECES WERE SHOWN INSIDE OF PATIENT. NOT SURE IF DAMAGE WAS DONE DURING SURGERY OR NOT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8486776 ↗
• MalfunctionOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DAMAGED INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7968843 ↗
• MalfunctionAug 24, 2018Problem with Sterilization; Problem with Sterilization

  SURGEONS FEEDBACK IS HE FEELS THE RUBBER RING WITHIN THE TRIAL NECK SEGMENTS ARE AN INFECTION RISK AND HAS CONCERNS ABOUT THE ABILITY FOR THE PRODUCT TO BE DECONTAMINATED AND STERILISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7813947 ↗
• MalfunctionApr 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS ALSO REPORTED THAT THE CORAIL KLA NECK TRIAL EXPANDABLE BUSHING HAS STRETCHED MAKING IT DIFFICULT TO TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7471896 ↗
• MalfunctionJul 21, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT BROACH AND NECK TRIAL DO NOT ENGAGE FULLY.

  Patient problems: No Information

  MAUDE report 6732144 ↗