CORAIL L94005Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10603295325161), received between Mar 12, 2018 and Sep 22, 2026 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (16 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  It was reported that prior to an unspecified surgical procedure it was observed that the colored green dot on the STD 135 neck trial device was discovered to be broken prior to surgery. It was reported that half of the colored dot was missing. It was reported that a spare device was available for use. It was reported that there was no delay in the procedure due to the event. It was reported that there was no injury to the patient or user. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852890 ↗
• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568638 ↗
• MalfunctionMar 4, 2026Contamination /Decontamination Problem; Detachment of Device or Device Component

  IT WAS REPORTED THE STANDARD NECK TRIAL IS MISSING THE LIGHT GREEN DOT, AND THEREFORE HAS A HOLE WITH DEBRIS INSIDE. THIS IS AN INFECTION RISK FROM THE CONSIGNMENT CORAIL BROACH TRAY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506776 ↗
• MalfunctionJul 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A THA SURGERY WITH CORAIL PERFORMED WITH THE PRODUCT IN QUESTION. IN THE SURGERY DURING THE TRIAL, THE CORAIL AMT BROACH SIZE 15 AND THE CORAIL AMT NECK SEGMENT KLA 125 DEGREES DID NOT FIT TOGETHER PROPERLY, WHICH EXTENDED THE PROCEDURE TIME BY ABOUT 15 MINUTES. AFTER SEVERAL TRIALS, IT WAS CONFIRMED THAT THE PRODUCTS FIT TOGETHER, BUT THEY COULD NOT BE ATTACHED OR DETACHED SMOOTHLY. THE SURGEON CHECKED FIVE NECKS OF THE PRODUCTS IN QUESTION, AND FOUND THAT, LIKE THE ISSUE IN QUESTION, THEY COULD BE FITTED TOGETHER BUT COULD NOT BE REMOVED SMOOTHLY. IN ADDITION, SINCE THE ISSUE WAS NOT CONFIRMED WITH OTHER SIZE BROACHES AND NECK SEGMENTS, THERE MAY BE A PROBLEM WITH THE CORAIL AMT BROACH SIZE 15. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 15 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396482 ↗
• MalfunctionMar 4, 2025Break; Break

  IT WAS REPORTED THAT THE CORAIL NECK TRIAL IS BROKEN PREOPERATIVELY. THE SMALL GREEN PIECE WHICH SIGNIFIES THE TRIAL SIZE HAS FALLEN OUT, MEANING THE SIZE OF THE NECK TRIAL CAN NO LONGER BE IDENTIFIED. THERE WAS NO HARM TO PATIENT AND NO DELAY TO SURGERY OCCURRED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518555 ↗
• MalfunctionSep 24, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED: THE EXACT COMPLAINT WAS THAT THE HEAD TRIAL WAS NOT LOCKING ONTO THE NECK TRIAL DUE TO THE LOCKING RING BEING BENT OUT OF SHAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295574 ↗
• MalfunctionJul 11, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: NO CHANGE TO THE NORMAL PATIENT STATUS/OUTCOME AT THIS STAGE. NORMAL POST-OP PROCEDURES BEING FOLLOWED. NOTHING TO REPORT OF INFECTION POST-OP AT THIS STAGE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725329 ↗
• MalfunctionJul 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENT WAS FAULTY.

  Patient problems: Insufficient Information

  MAUDE report 19716380 ↗
• MalfunctionJun 25, 2024Break; Break

  BROKEN CORAIL NECK TRIAL AND DAMAGED CORAIL EXTRACTOR THREAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610663 ↗
• MalfunctionFeb 13, 2024Break; Break

  NECK TRIAL MISSING IDENTIFYING PIECE OF PLASTIC REQUIRE REPLACEMENT. DISCOVERED UPON FIELD INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18698303 ↗
• MalfunctionAug 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GREEN COLOR CODE CAME OUT OF TRIAL WHEN WASHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597296 ↗
• MalfunctionMar 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT 135 STD CORAIL NECK TRIAL NOT LOCKING ON TO BROACH PROPERLY. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16642527 ↗
• MalfunctionOct 24, 2022Device-Device Incompatibility; Material Deformation; Material Integrity Problem; Device-Device Incompatibility; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE 8.5 HEAD TRAIL WOULD NOT DISENGAGE FROM NECK AT END OF PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658872 ↗
• MalfunctionOct 6, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  WORN INSTRUMENTS IDENTIFIED BY STERILISATION , DID NOT OCCUR DURING SURGERY SO NO SURGEON WAS INVOLVED. THE RETAINING RING IS DAMAGED AND WILL NOT ACCEPT A TRIAL HEAD. THE DRILL DID NOT FIT INTO THE DRIVER, OTHER DRILLS FITTED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15550245 ↗
• MalfunctionJul 12, 2022Off-Label Use; Device-Device Incompatibility; Off-Label Use; Device-Device Incompatibility

  IT WAS REPORTED THAT NECK TRIAL WAS DIFFICULT TO REMOVE FROM HANDLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986184 ↗
• MalfunctionMay 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A THR OPERATION WITH THE SURGEON AT (B)(6), DURING THE TRIAL PHASE OF THE OPERATION, HE STATED THE NECK TRIAL WAS NOT ENGAGING ON BROACH AS IT NORMALLY DOES, AS IT WAS GETTING STUCK AND NEEDED EXTRA FORCE TO SEAT THE NECK TRIAL FLUSH ONTO THE BROACH. THIS ISSUE DID NOT CAUSE ANY DELAYS, HOWEVER THE SURGEON HAS REQUESTED THE INSTRUMENTS BE REPLACED OR SERVICED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14399181 ↗
• MalfunctionMay 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A THA SURGERY FOR OA. THE SURGEON PERFORMED FINAL RASPING USING THE BROACH AND THEN MOVED ON TO A PROCEDURE USING A TRIAL DEVICE. WHEN THE SURGEON TRIED TO ATTACH THE NECK SEGMENT TO THE NECK OF THE BROACH, THEY DID NOT ENGAGE WELL. THE SURGEON REMOVED THE BROACH ONCE AND TRIED TO ENGAGE THE BROACH AND NECK SEGMENT AT THE OUTSIDE OF THE BODY, BUT IT WAS ALSO DIFFICULT TO ENGAGE. THE NECK SEGMENT WAS FORCEFULLY PUSHED INTO THE BROACH, AND THE NECK SEGMENT AND BROACH COULD NOT BE SEPARATED THIS TIME AND WAS FINALLY SEPARATED USING ELEVATORS. THE SURGEON GAVE UP USING THE NECK SEGMENT AND USED ANOTHER PRODUCT FOR A TRIAL PROCEDURE. AFTER THAT, A REAL IMPLANT WAS INSERTED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. AFTER SURGERY, THE PRODUCTS IN QUESTION WERE CHECKED, AND A SCRATCH WAS FOUND ON THE NECK OF THE BROACH. AGAIN, THE NECK SEGMENT DID NOT ENGAGE SMOOTHLY WITH THE BROACH. SINCE THE SCRATCH DID NOT SEEMED TO BE OBSERVED AT THE TIME OF THE PREOPERATIVE INSPECTION, IT IS CONSIDERED THAT THE CAUSE OF THE SCRATCH ON THE BROACH WAS THE BROACH HANDLES USED IN A RASPING PROCEDURE. NO FURTHER INFORMATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14396504 ↗
• MalfunctionApr 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE NECK SEGMENT CANNOT BE SECURED ON THE BROACH SIZE 13.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14208808 ↗
• MalfunctionApr 6, 2022Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  THE STANDARD TRIAL NECK SEGMENT HOLE ON THE BOTTOM IS ¿SCRATCHED/MARKED UP¿ AND DOES NOT PROPERLY CONNECT TO THE TRIAL BROACHES DURING TRIAL AND REDUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14023835 ↗
• MalfunctionMar 30, 2022Break; Break

  EMAIL RECEIVED FROM (B)(6) WITH A LIST OF BROKEN INSTRUMENTS FROM THE LAST WEEK. EMAIL CONTAINS LIST OF INSTRUMENTS AND CORRESPONDING CODES. NO DESCRIPTION OF DAMAGE OR CONTEXT OF HOW THEY BROKE IS PROVIDED, ONLY THE ITEMS WITH CODES. ALL THIS INFORMATION WILL BE FOLLOWED UP IN COMING DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13952615 ↗
• MalfunctionMar 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE NECK SEGMENT CANNOT BE SECURED ON THE BROACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635610 ↗
• MalfunctionJan 13, 2022Material Integrity Problem; Material Integrity Problem

  DAMAGED RETENTION RING ON CORAIL NECK TRIAL. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13250504 ↗
• MalfunctionOct 12, 2021Break; Break

  THE TRIAL´S COLOR MARKING IS FRACTURED INTO TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616402 ↗
• MalfunctionJul 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CUSTOMER IS COMPLAINING THE INSTRUMENT AS IT IS EXTREMELY HARD TO ASSEMBLE/DISASSEMBLE IT WITH/FROM THE TRIAL STEM. NO SURGICAL DELAY, NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10320712 ↗
• MalfunctionFeb 28, 2020Use of Device Problem; Component Missing; Use of Device Problem; Component Missing

  IT WAS REPORTED THAT PRIOR TO PROCEDURE START, REP NOTICED TRIAL NECK WAS MISSING A LACKING RING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771495 ↗