Xspan Laminoplasty Fixation System T085-0010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697T08500101), received between Mar 9, 2023 and Mar 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 16, 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.

• MalfunctionMar 9, 2023Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 2/15/2023. IT WAS REPORTED THAT THE DISTAL HEX TIP OF TWO SYSTEM SCREWDRIVERS MALFUNCTIONED DURING A SURGICAL PROCEDURE AND WERE REQUESTED TO BE REPLACED. A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENTS, WHICH AS OF 3/08/2023 HAVE NOT BEEN RECEIVED AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT. NO ADDITIONAL INFORMATION WAS INITIALLY AVAILABLE, AND REQUESTS FOR RELEVANT COMPLIANT INCIDENT INFORMATION AND RETURN OF THE COMPLAINT INSTRUMENTS WERE MADE ON 2/15/2023, 2/21/2023, 2/27/2023, 3/02/2023, 3/06/2023, AND 3/07/2023.

  Patient problems: Insufficient Information

  MAUDE report 16518745 ↗