MILAGRO 231812Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705020423), received between Aug 6, 2018 and Mar 15, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2024Break; Break

  REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED BY SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT A 8X15MM MILAGRO INTERFERENCE SCREW, 5X12MM MILAGRO INTERFERENCE SCREW, 8X23MM MILAGRO ADVANCE INTERFERENCE SCREW AND 10X23MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICES WERE BROKEN. IT WAS REPORTED THAT THE PATIENT HAD EXTREMELY HARD BONE, AND IT WAS A REVISION CASE. IT WAS REPORTED THAT THE SAME LARGE TUNNELS WERE USED AND THE DOCTOR WANTED TO START WITH A LARGER SCREW BUT IT WOULD NOT DRIVE EVEN AFTER NOTCHING AND TAPPING FOUR TIMES. ACCORDING TO THE REPORTER, MULTIPLE SCREWS WERE TRIED, THEY ALL ENDED UP BREAKING AND THE BROKEN SCREW STAYED INSIDE THE PATIENT AS IT WASN'T BADLY BROKEN SINCE IT WAS STILL HOLDING THE GRAFT IN PLACE. IT WAS REPORTED THAT THE DOCTOR LEFT THE LEFT BROKEN SCREW INSIDE PATIENT AS IT HELD THE GRAFT BUT BROKE IN HALF. 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 18911160 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMERS MILAGRO BR SCREW 8X15MM BROKE ONCE INSERTED 3/4 WAY IN, SO THE SURGEON BACKED THE SCREW OUT, AND USED ANOTHER LIKE DEVICE IN THE SAME BONE HOLE TO COMPLETE THE PROCEDURE, WITH NO PATIENT CONSEQUENCES AND NO DELAY. THE SALES REP IS REQUEST THAT ONLY HIS TRUCK STOCK BE ADJUSTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7753456 ↗