iFuse TORQ Implant System 10090TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810055520145), received between Nov 23, 2021 and Nov 23, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K203247); they may or may not involve this specific model.

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.

• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS NO PROBLEM WITH THE SI JOINT IMPLANTS OR THE PLACEMENT OF THE SI JOINT IMPLANTS. THE PATIENT HAD BILATERAL SI JOINT FUSION IN CONJUNCTION WITH A LUMBAR FUSION IN (B)(6) 2021. THE PATIENT LATER DEVELOPED AN INFECTION AT THE SURGERY SITE ON THE LEFT SIDE. A DIFFERENT SURGEON DECIDED TO REMOVE AND REPLACE ALL SI JOINT AND SPINAL HARDWARE AS A PRECAUTION. ANTIBIOTIC BEADS WERE ALSO PLACED AT THE SITE. THERE IS NO INDICATION THAT THE SI JOINT IMPLANTS WERE THE SOURCE OF THE INFECTION. THE SI JOINT IMPLANTS WERE REPLACED WITH IMPLANTS OF THE SAME TYPE.

  Patient problems: Cellulitis

  MAUDE report 12862599 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203247. One submission often covers many models, so check the product and lot details in each record.

• Z-0146-2027 · Aug 21, 2026 · Open, Classified
  iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)