XRL 03.807.313Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034723150), received between Aug 18, 2022 and Aug 18, 2022 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K103320); 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.

• MalfunctionAug 18, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE PREPARATION FOR IMPLANTATION OF A XRL CAGE, THE ASSEMBLY OF THE IMPLANT HOLDER AND IT WAS NOTICED THAT THE XRL RELEASE TOOL DID NOT HOLD TIGHT IN THE SHAFT AND THE TACTILE FEEDBACK OF THE RESTING POSITION AND THE END POSITION WAS VERY WEAK. AFTER CONNECTING TO THE IMPLANT, THE IMPLANT WAS EXPANDED FOR TEST OVER THE BACK TABLE (NOT IN SITU). IT WAS THEN NOTICED THAT THE RELEASE TOOL WAS SLIPPING BACK OUT OF THE SHAFT AND HAD TO BE HOLD IN PLACE BY HAND. AS THE IMPLANT HAD TO BE COLLAPSED, IT WAS NOT POSSIBLE (HANDLE ON OF, RELEASE TOOL IN PLACE) TO TURN THE HANDLE COUNTERCLOCKWISE AND COLLAPSE THE IMPLANT. THERE WAS A SURGICAL DELAY OF 10 MINUTES. A SECOND IMPLANT WAS UNWRAPPED AN IMPLANTED WITH CONSTANT PRESSURE ON THE RELEASE TOOL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) XRL MEDIUM SPREADER TOP WITH 8MM DISTRACTION. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248332 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103320. One submission often covers many models, so check the product and lot details in each record.

• Z-1681-2014 · Apr 8, 2014 · Terminated
  Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is