MILAGRO 231825Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705010806), received between Jul 27, 2018 and Sep 3, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP IN INDIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE ON (B)(6) 2024 WHILE USING THE CORTICAL FXATION FXD LOOP 20MM DEVICE AND THE MILAGRO INTSCR 9X30MM *EA ON FEMUR SIDE THE SURGERY WENT WELL AND THE PATIENT WAS DISCHARGED. AFTER TWO TO THREE MONTHS THE PATIENT SHOWED SIGN ON INFECTION AT THE OPERATED SITE AND TOOK ADVICE FROM OTHER SURGEON, WHO AFTER CHECKING THE PATIENT REPORTED AND IMPLANTS COMMENTED TO THE PATIENT ABOUT SUB STANDARD IMPLANTS USED. THE PATIENT HAS FILED COMPLIANT AGAINST OPERATIVE SURGEON DOCTOR OF NORTH STAR MULTISPECIALTY HOSPITAL KOLHAPUR. HOSPITAL HAS REQUESTED FROM COMPANY A QUALITY CERTIFICATE TO FURTHER ENDORSED CLINICALLY PROVEN IMPLANTS WERE USED IN THE SURGERY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENTS.

  Patient problems: Unspecified Infection

  MAUDE report 20124690 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING A POSTERIOR CRUCIATE LIGAMENT (PCL) RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE MILAGRO INTSCR 9X30MM DEVICE WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605601 ↗
• MalfunctionMar 6, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ACL (ANT.CRUCIATE LIGAMENT) REPAIR SURGERY ON (B)(6) 2024, IT WAS OBSERVED THAT THE MILAGRO INTERFERENCE SCREW, 9 X 30MM DEVICE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844604 ↗
• MalfunctionAug 27, 2018Break; Break

  IT WAS REPORTED THAT AS THE SURGEON WAS SCREWING THE SCREW INTO THE TIBIA, THE TIP OF THE IMPLANT BROKE. REPORT ONLY, DEVICE WAS DISCARDED BY THE CUSTOMER. THE PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7819950 ↗
• MalfunctionJul 27, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN VIETNAM THAT DURING A KIDNEY SURGERY, IT WAS OBSERVED THAT THE MILAGRO INTERFERENCE SCREW, 9 X 30MM WAS BROKEN WHEN THE SURGEON SCREWED IT INTO THE TIBIAL TUNNEL. THE SURGEON HAD TO USE ANOTHER SCREW TO KEEP THE GAFT STABILITY INTO TUNNEL. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7725807 ↗