MILAGRO 231867Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705026432), received between Aug 3, 2020 and Dec 5, 2020 — classified as 2 injuries.

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

• InjuryDec 5, 2020Migration; Migration

  THE SURGEON ADVISED THAT A PATIENT THAT HAD AN ACL RECONSTRUCTION ON THE (B)(6) 2017 HAD RECENTLY PRESENTED TO HIS CLINIC WITH A BULGE AT THE SITE OF THE TIBIAL TUNNEL. THE SURGEON ARRANGED FOR THE PATIENT TO HAVE A SCAN AND IT HIGHLIGHTED THAT THE MILAGRO SCREW HAD "BACKED" OUT OF THE TUNNEL. THE SURGEON REQUESTED THE PATIENT ATTEND CLINIC ON WEDNESDAY THE (B)(6) 2020 AND UNDER A LOCAL ANESTHETIC MADE AN INCISION AND REMOVED THE SCREW.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10950711 ↗
• InjuryAug 3, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT POST-IMPLANT TO PRIMARY ACL SURGERY CARRIED OUT IN (B)(6) 2017, THE PATIENT RETURNED TO CLINIC THIS WEEK COMPLAINING OF PROTRUSION AND ON SCAN IT WAS NOTED THAT THE TIBIAL INTERFERENCE SCREW HAD "BACKED OUT" OF THE TIBIAL TUNNEL. A CLINICAL EVALUATION HAS NOT YET BEEN CONDUCTED TO DETERMINE WHETHER THE GRAFT HAS INTEGRATED AND WHETHER THE KNEE IS STABLE. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED REVISION SURGERY HAS NOT BEEN CARRIED OUT YET AND THE SURGEON HAS NOT YET SET A DATE. THE AFFILIATE ALSO REPORTED SURGEON IS UNABLE TO DETERMINE WHETHER INITIAL REPAIR HAS HEALED OR IS INTACT. HOWEVER IT WAS REPORTED THE SURGEON DID INDICATE THAT ACCORDING TO THE MRI IT LOOKS LIKE THE INITIAL GRAFT IS INTACT. ADDITIONALLY, AN MRI WAS REQUIRED AND THE PATIENT WAS REFERRED TO A SURGEON.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10358147 ↗