MULTILOC 04.019.300SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982090126), received between Oct 3, 2019 and May 19, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

   IT WAS REPORTED THAT, PATIENT UNDERWENT REVISION SURGERY DUE TO NONUNION. THE PATIENT HAD SUSTAINED AN OPEN HUMERUS FRACTURE THAT WAS TEMPORARILY PUT IN AN EXTERNAL FIXATOR AND EVENTUALLY NAILED WITH MULTILOC NAIL. THE SCREWS THROUGH THE NAIL HAD QUITE A BIT OF BONY OVERGROWTH WHICH MADE THEM DIFFICULT TO REMOVE. THEY ARE ALL SUCCESSFULLY REMOVED INTACT, AND THE NAIL WAS REMOVED SUCCESSFULLY. THE NONUNION FRACTURE WAS THEN FIXATED WITH AN EXTRA-ARTICULAR DISTAL HUMERUS PLATE ALONG WITH A 3.5 LCP PLATE. THIS REPORT IS FOR ONE (1) 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/300MM-STERILE. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11848674 ↗
• MalfunctionOct 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, WHEN PLACING THE TITANIUM MULTILOC SCREW, IT MISSED THE TITANIUM MULTILOC HUMERAL NAIL AND IS NEXT TO IT INSIDE THE BONE. IT APPEARS THE NAIL ROTATED AFTER DRILLING THE SCREW HOLE THEREFORE DEFLECTING THE SCREW. THE SURGEON PLANS ON LEAVING IT AS IS. THIS ISSUE WAS DISCOVERED ON A POST-OPERATIVE X-RAY AFTER SURGERY WAS COMPLETED. PATIENT STATUS IS STABLE. THIS REPORT IS FOR ONE (1) 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/300MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9150278 ↗