MILAGRO 231826Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705022304), received between Nov 6, 2018 and Oct 30, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHILE AS FOLLOWS: T WAS REPORTED BY THE AFFILIATE THAT DURING AN UNKNOWN PROCEDURE THE MILAGRO ADVANCE SCREW 9X35MM SPLIT INTO TWO AT THE TIME OF PLACING IT WITH THE NECESSARY FORCE. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256729 ↗
• MalfunctionJan 4, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE MILAGRO ADVANCE 9X35 SCREW BROKE WHILE IT WAS BEING TIGHTENED. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2019. 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 8218619 ↗
• MalfunctionNov 6, 2018Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SURGICAL PROCEDURE FOR A RUPTURED ANTERIOR CRUCIATE LIGAMENT, IT WAS OBSERVED THAT THE GUIDE-WIRE AND THE MILAGRO-SCREW BROKE UPON INSERTION OF THE TIBIAL SCREW. IT WAS REPORTED THAT THE SURGERY WAS PROLONGED BY FOUR MINUTES BUT NEW SCREWS AND NEW WIRE WERE USED TO COMPLETE THE SURGERY. IT WAS REPORTED THAT EVERYTHING WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT ALL DEVICES HAVE BEEN DISCARDED BY THE CUSTOMER. 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: Not Applicable

  MAUDE report 8041437 ↗