iFuse TORQ Implant System 10090LGRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810055520251), received between Dec 21, 2021 and Dec 21, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

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.

• InjuryDec 21, 2021Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WITH PELVIC TRAUMA INJURY HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE ONE IMPLANT WAS INSTALLED. LATER THE SURGEON DETERMINED THAT THE IMPLANT WAS LOOSE. IN (B)(6) 2021, SURGEON PERFORMED A REVISION PROCEDURE WHERE THE IMPLANT WAS REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 13056500 ↗

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)