MULTILOC 04.018.240SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982089465), received between Oct 21, 2022 and Jan 14, 2025 — classified as 2 injuries.

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 18, 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.

• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR HUMERAL DIAPHYSEAL FRACTURE WITH THE PRODUCTS IN QUESTION. AFTER THE SURGERY, THE SWELLING WAS OBSERVED DUE TO HEMATOMA ACCUMULATION AT THE DISTAL TRANSVERSE STOP SCREW HEAD. A REMOVAL SURGERY WAS PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, IT WAS OBSERVED THAT THE PULLED NAIL BODY AND THE SIDE STOPPER SCREW WERE COLORED IN A SPECKLED STATE. THE SURGEON OPINES THAT IT WAS CAUSED BY THE INFECTION.

  Patient problems: Hematoma; Swelling/ Edema; Unspecified Infection

  MAUDE report 21147540 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS FRACTURE FIXATION OF THE LONG BONES. NONUNION AND NO SURGICAL INTERVENTION WAS REPORTED. THIS REPORT INVOLVES ONE (1) 8.5MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/240MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15649763 ↗