CORAIL L98515Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295262633), received between Jun 12, 2020 and Dec 13, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Break; Material Deformation; Break; Material Deformation

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE DISTAL SPLINES WERE BENT. THERE WAS SURGICAL DELAY APPROXIMATELY 10 MINS.

  Patient problems: Insufficient Information

  MAUDE report 20929008 ↗
• MalfunctionJul 8, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TRUNNION OF THE NECK ON THE TRIAL STEM IS DEFORMED (BENT) AND WILL NOT CONNECT TO THE BROACH HANDLE OR NECK TRIALS. PLEASE REORDER TO MULLER¿S HOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12137732 ↗
• InjuryJun 12, 2020Material Twisted/Bent; Material Twisted/Bent

  DEFORMED CORAIL REVISION STEM AND TRIAL AFTER IMPLANTING. ONE OF THE DISTAL PARTS IS GOING OUTSIDE THE BONE BECAUSE OF A VIA FALSA. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> YES, IF YES, NUMBER OF MINUTES: --> 45, ACTION TAKEN WHEN EVENT OCCURRED? --> INTRAOPERATIVE RX TO CONTROL THE POSITION, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> UNKNOWN, 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: Bone Fracture(s); No Code Available; Not Applicable

  MAUDE report 10148486 ↗