XRL 03.807.348Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034723242), received between Aug 24, 2021 and Jan 31, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2024, THE XRL RELEASE TOOL BROKE WHEN THE SURGEON WAS TRYING TO DETACH IT. THE TOP METAL PART THAT IS MADE FOR HAMMERING BROKE FROM THE REST OF THE INSTRUMENT. THE SURGERY WAS DELAYED BY FIVE MINUTES, AND WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN XRL RELEASE TOOL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614820 ↗
• MalfunctionDec 14, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ISRAEL AS FOLLOWS: IT WAS REPORTED THAT ON ( B)(6) 2023, DURING THE SURGERY THAT TOOK PLACE AT THE HOSPITAL. A FAULTY ITEM WAS DISCOVERED IN THE XRL SPREADER CAGE HOLDER SET. THE SURGEON CONNECTED TO THE CAGE, BUT THE CAGE HOLDER WAS UNABLE TO OPEN THE CAGE. THERE WAS NO CLAIM AGAINST THE CAGE. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) XRL RELEASE TOOL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329096 ↗
• MalfunctionAug 2, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE END HANDLE/KNOB DETACHED FROM RELEASE TOOL FOLLOWING USE IN THEATRE. THIS REPORT INVOLVES ONE (1) XRL RELEASE TOOL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17443672 ↗
• MalfunctionJun 23, 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 RELEASE TOOL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14789594 ↗
• MalfunctionAug 24, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT WAS DIFFICULT TO WORK WITH AND BECAME STUCK. THE ISSUE WAS DISCOVERED PRIOR TO A PROCEDURE. THIS REPORT INVOLVES ONE (1) XRL RELEASE TOOL. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12361397 ↗

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