Silex Sacroiliac Joint Fusion System X079-1255PC-DTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697X0791255PCDT1), received between Jan 24, 2020 and Jan 24, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryJan 24, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  FOLLOWING SUBMISSION OF 3005031160-2019-00064, THE COMPLAINANT PROVIDED ADDITIONAL INFORMATION REGARDING THE REPORTABLE EVENT, INCLUDING THAT TWO DEVICES WERE EXPLANTED DURING THE REVISION SURGERY. THIS MDR IS TO ACCOUNT FOR THE SECOND DEVICE THAT WAS EXPLANTED. THE INITIAL COMPLAINT REPORTED THAT A PATIENT WAS SCHEDULED TO UNDERGO A REVISION SURGERY DUE TO PAIN FROM A PREVIOUS SACROILIAC JOINT FUSION PROCEDURE. THE COMPLAINANT REPORTED THAT THE ORIGINAL PROCEDURE WAS COMPLETED WITHOUT COMPLICATION ON (B)(6) 2019. THE IMPLANTS WERE NOT LOOSE, AND GOOD FUSION HAD BEEN ACHIEVED. THE REVISION WAS PERFORMED ON (B)(6) 2019 BECAUSE THE PATIENT STILL HAD PAIN BUT RESPONDED POSITIVELY TO INFILTRATION. THE FOLLOWING MDRS ARE ASSOCIATED WITH THIS EVENT. 3005031160-2019-00064; 3005031160-2019-00064-001.

  Patient problems: Pain

  MAUDE report 9630067 ↗