iFuse TORQ Implant System 10060TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810055520084), received between Nov 2, 2021 and Nov 2, 2021 — classified as 1 injury.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 21, 2026Open, Classified

   The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.

   Z-0146-2027 · Root cause: Packaging · Recall details · FDA record ↗

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 2, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE TWO SCREW TYPE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE THE INFERIOR POSITIONED IMPLANT WAS REMOVED AND REPLACED WITH A SHORTER IMPLANT OF THE SAME TYPE USING THE EXPLANT VOID. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12738841 ↗