Silex Sacroiliac Joint Fusion System X079-1250PC-DTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697X0791250PCDT1), received between Dec 3, 2018 and Dec 3, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• InjuryDec 3, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE COMPANY WAS CONTACTED TO OBTAIN THE APPLICABLE SURGICAL TECHNIQUE GUIDE. HE REPORTED THAT A PATIENT ALLEGED THAT THE PHYSICIAN DID NOT PROPERLY SEAT THE IMPLANTS DURING THE SURGICAL PROCEDURE WHICH LEFT THEM PROTRUDING AND SEVERING THE LEFT GLUTEAL ARTERY. THE ARTERY HAS BEEN PERMANENTLY SEVERED, WHICH RESULTS IN EXTREME PAIN WHEN PATIENT ATTEMPTS TO AMBULATE ANY DISTANCE.

  Patient problems: Ambulation or Postural Difficulties; Perforation of Vessels

  MAUDE report 8127189 ↗