8.7 mm X 160 mm iFuse TORQ TNT Implant 870160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810055524402), received between Jun 13, 2025 and Jun 13, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 18, 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.

• InjuryJun 13, 2025Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT IS A WOMAN OF APPROXIMATELY 70 YEARS. SHE HAD A FALL AT HOME WITH A U-TYPE SACRAL FRACTURE AND RIGHT PUBIC RAMUS FRACTURE. THE SURGEON PLACED ONE SI-BONE TORQ TNT TRANSILIAC TRANSSACRAL SCREW AND ONE STANDARD TRANSILIAC TRANSSACRAL SCREW IN THE S1 CORRIDOR. IFUSE TORQ TNT WAS PLACED IN/NEAR THE TRANSVERSE FRACTURE LINE OF THE SACRAL U TYPE FRACTURE. IFUSE TORQ TNT WAS REPORTED TO HAVE GOOD DISTAL ILIUM PURCHASE, AND THE CASE WAS COMPLETED WITHOUT ANY PROBLEMS. ADDITIONALLY, A NON-SI-BONE SCREW WAS PLACED IN THE PUBIC RAMUS. THE PATIENT HAD BACK PAIN AFTER SURGERY. MRI SHOWED MULTIPLE DISC PROBLEMS AT L3-L4, L4-L5, AND L5-S1. AT ABOUT TWO WEEKS AFTER THE INITIAL PELVIC SURGERY, THE PATIENT UNDERWENT LAMINECTOMY/DISCECTOMY. THE PATIENT FELL AT AN ASSISTED LIVING FACILITY POSTOPERATIVELY. CT SCAN SHOWED IFUSE TORQ TNT BACKOUT. THE PATIENT WAS MEDICALLY COMPLICATED, WITH SEPSIS FROM UTI, AS WELL AS WOUND DEHISCENCE IN LUMBAR SPINE WOUND. THE PATIENT WAS NOTED TO BE MOVING AROUND A LOT IN BED POSTOPERATIVELY. THE PATIENT UNDERWENT LUMBOPELVIC SPINE FIXATION SURGERY, IN WHICH THE IFUSE TORQ TNT WAS REMOVED AND PELVIC FIXATION SCREWS WERE PLACED. THE SURGEON DID NOT KNOW THE C

  Patient problems: Inadequate Osseointegration

  MAUDE report 22205209 ↗