XRL 03.807.300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034723112), received between Aug 24, 2021 and Aug 18, 2022 — classified as 4 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. 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 4 most recent of 4 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 SPREADER. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248305 ↗
• MalfunctionOct 26, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, INTRAOPERATIVELY A SMALL SPRING INTERNALLY GOT BROKEN OR MISALIGNED AND WAS CAPTURED INSIDE THE EXTENDER. THE FUNCTION OF THE INSTRUMENT BECAME UNCOMFORTABLE WITHOUT THE RATCHET FUNCTION, BUT POSITIONING AND LOCKING THE XRL IMPLANT WAS PERFORMED SAFE AND FAST. THE CAGE NEEDED TO BE SECURED BY HAND BECAUSE THE LOCKING MECHANISM DID NOT WORK ANYMORE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) XRL SPREADER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698794 ↗
• MalfunctionOct 1, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT FOLLOWING A LUMBAR CORPECTOMY ON SEPTEMBER 2, 2021, THE ON/OFF BUTTON OF AN XRL INSERTER WAS STUCK. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN XRL SPREADER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12563417 ↗
• 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 BECOME STUCK. THE ISSUE WAS DISCOVERED PRIOR TO A PROCEDURE. THIS REPORT INVOLVES ONE (1) XRL SPREADER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12361273 ↗

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