iFuse TORQ Implant System 10045TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810055520053), received between Nov 22, 2021 and Nov 22, 2021 — classified as 1 injury.

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

• InjuryNov 22, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE TWO SCREW TYPE IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT HAD SI JOINT PAIN RELIEF FOLLOWING THE INITIAL PROCEDURE, BUT LATER COMPLAINED OF LEFT SIDE RADICULAR PAIN. THE SURGEON DETERMINED THAT THE LEFT SIDE INFERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE THE LEFT SIDE INFERIOR POSITIONED IMPLANT. 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 12857246 ↗

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)