TransLoc 3D TS85-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850026642070), received between May 13, 2024 and May 13, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2024Malposition of Device; Malposition of Device

  SI JOINT FUSION IMPLANT (SCREW) WAS MALPOSITIONED UPON IMPLANTATION. ATTEMPTS TO BACK UP THE IMPLANT TO A MORE IDEAL DEPTH INCREASED THE MALPOSTION. THE BONE WAS NOTED BY THE OPERATIVE PHYSICIAN TO BE "QUITE SOFT." ATTEMPTS TO RETRIEVE THE IMPLANT WITH A CLAMP RESULTED IN THE IMPLANT ADVANCING INTO THE PRESACRAL SPACE. PATIENT PROCEDURE WAS CONCLUDED, AND THE OPERATIVE INCISION WAS CLOSED. THE PATIENT WAS TRANSPORTED TO THE ER FOR EVALUATION BY A VASCULAR SURGEON WHERE A CTA SCAN WAS PERFORMED. PATIENT REMAINED STABLE THROUGHOUT. PATIENT WAS RELEASED FROM THE ER WITHOUT INTERVENTION OR REMOVAL OF THE IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 19305593 ↗