TiLock 1 (REF GLC124-S)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M719GLC124S0), received between Oct 30, 2019 and Oct 30, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K100757); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 30, 2019Break; Break

  THE COMPLAINANT REACHED OUT TO GENESYS SPINE TO REPORT THAT TWO (2) NITINOL GUIDEWIRES HAD BROKEN DURING AN MIS PROCEDURE. THE COMPLAINANT REPORTED THAT THE PATIENT HAD "VERY, VERY HARD AND DENSE BONE" BUT THE SURGEON DID NOT NOTE ANY OTHER UNUSUAL OCCURENCE UNTIL HE TRIED TO REMOVE THE WIRES AFTER SCREW PLACEMENT. AT THIS POINT THE WIRES FELT "STUCK" AND WERE DIFFICULT TO REMOVE. THE SURGEON HAD TO ATTACH INSTRUMENTATION TO THE WIRES TO PULL HARD ENOUGH TO REMOVE THEM FROM THE SCREWS HOWEVER, IN DOING SO, BROKE OFF THE TIPS OF THE WIRES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9256708 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100757. One submission often covers many models, so check the product and lot details in each record.

• Z-2677-2014 · Apr 2, 2014 · Terminated
  Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide i