TiLink-P Screw 12mm x 25mm SI-SGT-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810131880842), received between May 14, 2025 and May 14, 2025 — classified as 1 death.

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.

• DeathMay 14, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE CASE WAS ON (B)(6) 2025 AT 7:30 AM. REP STATED THAT IT WAS A ROUTINE CASE. REP ALSO STATED THERE WAS MINOR BLEEDING THAT OCCURRED DURING THE SURGERY, AND THEY HAD IT UNDER CONTROL IN LESS THAN A MINUTE. REP ALSO STATED THAT NO SURGENTEC INSTRUMENTS WERE FAULTY OR HAD ANY ISSUES PRIOR TO OR DURING THE CASE. THE PATIENT DID NOT STAY UNDER ANESTHESIA LONGER THAN ORIGINALLY ANTICIPATED. THE REP THEN STATED THAT THE PATIENT STOOD UP 6.5 HOURS POST-OP AND EXPERIENCED A VASCULAR ISSUE. THE PATIENT THEN ULTIMATELY PASSED AWAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22019293 ↗