CORAIL L20431Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10603295258216), received between Jul 21, 2017 and Jun 12, 2026 — classified as 58 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (25 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT CORAIL STANDARD NECK SEGMENT WOULD NOT MATE TO THE BROACH. BROACH WAS GOOD BUT NECK SEGMENT WAS BAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25484465 ↗
• MalfunctionFeb 24, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK OF THE STD NECK SEGMENT CORAIL AMT INSTRUMENT WOULD NOT AFFIX TO BROACHES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431251 ↗
• MalfunctionOct 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH AND NECK STUCK TOGETHER. IT WAS A STRUGGLE TO ATTACH THE BROACH TO THE HANDLE SO LIKELY THE TRUNNION IS DAMAGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435098 ↗
• MalfunctionMay 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT CORAIL AMT NECK SEG 135D STD AND BROACH CORAIL SIZE 14, GOT STUCK TOGETHER WHEN TRIALING AND CANNOT BE SEPARATED. THE INSTRUMENTS SUMMIT STANDARD IMP. INSERTER AND QUICKSET TAPER HEX SCDR RIGID HAS A WORN OUT THREADS/TIP WHICH TENDS FOR THE IMPLANT TO GET STUCK AS WELL. ANOTHER SET WAS OPENED TO USE. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO ADDITIONAL TIME REQUIRED ONLY WAS WHEN OPENING FOR ANOTHER SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054855 ↗
• MalfunctionMar 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIP OF THE SIZE 8 BROACH APPEARED TO HAVE A DEFECT WHICH WOULD NOT ALLOW THE NECK TO SIT FLUSH. THERE WAS NO IMPACT TO THE PATIENT; THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655346 ↗
• MalfunctionJul 23, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE NECK SEGMENT IS DAMAGED. NO PATIENT IMPLICATIONS OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810635 ↗
• MalfunctionJul 23, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE NECK SEGMENT IS DAMAGED. NO PATIENT IMPLICATIONS OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810627 ↗
• MalfunctionJul 23, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE NECK SEGMENT IS DAMAGED. NO PATIENT IMPLICATIONS OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809752 ↗
• MalfunctionJul 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENT WAS FAULTY.

  Patient problems: Insufficient Information

  MAUDE report 19715438 ↗
• MalfunctionMay 3, 2023Break; Break

  IT WAS REPORTED THAT THE RUBBER RING BUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860186 ↗
• 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 ((B)(6) 2023). THE HEADS ARE ALL SCRATCHED AND DAMAGED AND THE SURGEON HAS COMPLAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396554 ↗
• MalfunctionJan 30, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE CORAIL STD NECK TRIAL RING BENT AND WILL NOT HOLD HEAD ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263853 ↗
• MalfunctionJan 3, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16088407 ↗
• MalfunctionJan 3, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THE 28 AND 32MM LINER IMPACTOR TIPS ARE BURRED AND SCRATCHED UP DUE TO WEAR AND TEAR. THE HEX LINER SCREWDRIVERS ARE STRIPPED ON THE BOTTOM AND HAVE WORN DOWN OVER TIME. THEY NO LONGER CONNECT INTO THE TRIAL LINER. THE PINNACLE STRAIGHT CUP INSERTERS HAVE BROKEN OFF STRIKE PLATES ON THE PROXIMAL END OF THE INSTRUMENT. THEY CAN NO LONGER IMPACT PINNACLE CUPS. THE STANDARD AND HIGH OFFSET NECK TRIALS ARE BURRED ON THE INSIDE AND NO LONGER CONNECT PROPERLY TO A TRIAL BROACH. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085707 ↗
• MalfunctionJan 3, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THE 28 AND 32MM LINER IMPACTOR TIPS ARE BURRED AND SCRATCHED UP DUE TO WEAR AND TEAR. THE HEX LINER SCREWDRIVERS ARE STRIPPED ON THE BOTTOM AND HAVE WORN DOWN OVER TIME. THEY NO LONGER CONNECT INTO THE TRIAL LINER. THE PINNACLE STRAIGHT CUP INSERTERS HAVE BROKEN OFF STRIKE PLATES ON THE PROXIMAL END OF THE INSTRUMENT. THEY CAN NO LONGER IMPACT PINNACLE CUPS. THE STANDARD AND HIGH OFFSET NECK TRIALS ARE BURRED ON THE INSIDE AND NO LONGER CONNECT PROPERLY TO A TRIAL BROACH. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085597 ↗
• MalfunctionJan 3, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THE 28 AND 32MM LINER IMPACTOR TIPS ARE BURRED AND SCRATCHED UP DUE TO WEAR AND TEAR. THE HEX LINER SCREWDRIVERS ARE STRIPPED ON THE BOTTOM AND HAVE WORN DOWN OVER TIME. THEY NO LONGER CONNECT INTO THE TRIAL LINER. THE PINNACLE STRAIGHT CUP INSERTERS HAVE BROKEN OFF STRIKE PLATES ON THE PROXIMAL END OF THE INSTRUMENT. THEY CAN NO LONGER IMPACT PINNACLE CUPS. THE STANDARD AND HIGH OFFSET NECK TRIALS ARE BURRED ON THE INSIDE AND NO LONGER CONNECT PROPERLY TO A TRIAL BROACH. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085566 ↗
• MalfunctionOct 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SURGEON COMPLAINED ABOUT HAVING TROUBLE SNAPPING THE FEMORAL HEAD TRIAL ON THE NECK. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668232 ↗
• MalfunctionAug 25, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  STAFF HAVE INDICATED 2X CORAIL STANDARD TRIAL NECK SEGMENTS NEED TO BE REPLACED. THEY NO LONGER ARTICULATE PROPERLY WITH THE TRIAL BROACHES. WHEN TRYING TO PUT THE NECK SEGMENT ON THE BROACH, IT WILL NOT FULLY SIT DOWN AND THEREFORE DUE TO WEAR AND TEAR ARE NO LONGER USABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293531 ↗
• MalfunctionAug 25, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  STAFF HAVE INDICATED 2X CORAIL STANDARD TRIAL NECK SEGMENTS NEED TO BE REPLACED. THEY NO LONGER ARTICULATE PROPERLY WITH THE TRIAL BROACHES. WHEN TRYING TO PUT THE NECK SEGMENT ON THE BROACH, IT WILL NOT FULLY SIT DOWN AND THEREFORE DUE TO WEAR AND TEAR ARE NO LONGER USABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293526 ↗
• MalfunctionAug 3, 2022Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL IS WORN AND CRACKED FROM REPEATED USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15155899 ↗
• MalfunctionJun 2, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE NECKS REQUIRE REPLACEMENT DUE TO RINGS ON NECK BEING WORN ABS STARTING TO DETACH. NO PATIENT IMPACT. 3 MINUTE DELAY IN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 14573784 ↗
• MalfunctionFeb 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE SPACER TRIAL AND THE CORAIL NECK WERE STUCK AND WOULD NOT COME APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472805 ↗
• MalfunctionDec 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NEXT SEGMENT WOULD NOT HOLD THE HEAD BALL PROPERLY. IT KEPT COMING LOOSE. PLEASE SEND A REPLACEMENT TO MISSION HOSPITAL. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094837 ↗
• MalfunctionDec 17, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE STD NECK TRIAL FOR CORAIL BROKEN. RING STICKS OUT AND IS DIFFICULT TO ATTACH HEAD TRIALS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025269 ↗
• MalfunctionDec 1, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY VIA BHP WITH THE BROACH AND NECK TRIAL IN QUESTION. DURING THE SURGERY, THE SURGEON TRIED TO ATTACH A NECK TRIAL INTO THE BROACH, BUT IT DID NOT GO SMOOTHLY. THE SURGEON STRUCK THE NECK TRIAL WITH A HAMMER, AND HE MANAGED TO ATTACH IT, BUT COULDN'T REMOVE THE TRAIL NECK. AND THEN, THE SURGEON OPENED THE GAP BETWEEN THE BROACH AND NECK TRIAL WITH CHISEL, AND HE STRUCK THE NECK TRIAL RETROGRADELY BY USING ELEVATORS WHICH HOSPITAL OWNS AND HE MANAGED TO REMOVE IT. THE SURGEON COMMENTED THAT PRODUCTS SUCH AS CORAIL AND ACTIS REQUIRE USING A CALCAR REAMER, BUT IT IS NOT SO SHARP. THE SURGEON GUESSES THAT WHEN CALCAR REAMING IS PERFORMED WITH TOO MUCH POWER, THE BROACH NECK WAS DAMAGED, AND IT COULDN'T BE ATTACHED THE TRAIL NECK. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12908086 ↗