MILAGRO 231868Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705026449), received between Mar 26, 2020 and Jul 12, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJul 12, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE OF THE LEFT KNEE ON (B)(6) 2021, IT WAS OBSERVED THAT THE MILAGRO ADV PEEK SCREW 9X30MM DEVICE BROKE UPON INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12151794 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP VIA COMPLAINT SUBMISSION TOOL THAT FOLLOWING AN ACL PROCEDURE THE MILAGRO ADV PEEK SCREW 9X30 MM INFECTED THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9886478 ↗