CORAIL L971115Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295455349), received between Apr 12, 2021 and Nov 16, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HETEROTOPIC OSSIFICANS & TINGLING IN THIGH ASSOCIATED WITH THE BONE GROWTH. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT HIP). ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT HIP SURGICAL INTERVENTION TO ADDRESS HETEROTOPIC OSSIFICATION. THE PATIENT WAS EXPERIENCING DECREASED RANGE OF MOTION PRIOR TO THE OPERATION. THE SURGEON NOTED A SMALL AMOUNT OF REMAINING NECROTIC BONE THAT WAS FAR POSTERIOR TO THE TIP OF THE TROCHANTER AND NOT GOING TO AFFECT ANY RANGE OF MOTION, THIS WAS LEFT. NO PRODUCTS WERE REVISED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT PRESENTED FOR A RIGHT HIP EVALUATION FOLLOWING HETEROTOPIC OSSIFICATION REMOVAL. THE PATIENT WAS CONTINUING TO EXPERIENCE PARESTHESIA AND INCREASED BURNING IN THE AREA. AN X-RAY REVEALED A SMALL PIECE OF BONE OFF THE GREATER TROCHANTER, HOWEVER, THE SURGEON THOUGHT IT WAS UNRELATED TO HETEROTOPIC OSSIFICATION, LIKELY A SMALL AVULSION. THE PATIENT WAS PRESCRIBED PO GABAPENTIN. THERE I

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Extraskeletal ossification; Loss of Range of Motion; Pain

  MAUDE report 12821124 ↗
• MalfunctionApr 12, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  CORAIL IMPLANT HAD A SMALL HOLE IN THE PACKAGING INTO THE STERILE COMPARTMENT. SURGERY DELAYED DUE TO THE REPORTED EVENT BY 2 MINUTES. PROCEDURE SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11651581 ↗