X-MESH 288900051Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034222875), received between Jan 10, 2020 and Jan 10, 2020 — classified as 1 malfunction.

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

• MalfunctionJan 10, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN SURGERY, WHILE USING THE X - MESH EXPANDABLE CAGE SYSTEM, IMPLANT X-MESH POS SM 0 DEG 25-33MM WAS EXPANDED AND TORQUED OUT. A FEW MINUTES LATER THE SURGEON WANTED TO READJUST THE POSITION OF THE IMPLANT. WHILE LOOSENING THE SET SCREW TO ALLOW THE CAGE TO COMPRESS, THE TORQUE DRIVER SNAPPED AND THE TIP BECAME COLD WELDED TO THE IMPLANT. THE IMPLANT WAS REMOVED FROM THE PATIENT AND ANOTHER IMPLANT WAS USED. THERE WAS NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: SET SCREWS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9575865 ↗