X-CORE D7185100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517403148), received between Aug 12, 2021 and Sep 1, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2022Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  DURING A VERTEBRAL BODY REPLACEMENT PROCEDURE AT L2 WITH THE X-CORE 2 SYSTEM, IT WAS REPORTED THE SURGEON HAD DIFFICULTY FULLY ENGAGING THE INSERTER WITH THE X-CORE IMPLANT. DURING THE PROCEDURE, AN INITIAL X-CORE IMPLANT WAS INSERTED INTO L2 BUT IT COULD NOT BE EXPANDED. TWO MORE X-CORE IMPLANTS WERE ATTEMPTED BUT SIMILAR PROBLEMS WERE ENCOUNTERED AFTER INSERTION INTO L2. A FOURTH X-CORE IMPLANT WAS USED AND SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT THE IMPLANTATION ISSUES DELAYED THE SURGERY BY APPROXIMATELY THREE HOURS. NO PATIENT INJURY OR CONSEQUENCE OCCURRED DURING THE PROCEDURE OR IMMEDIATELY POST-OP. HOWEVER, ON A SUBSEQUENT, UNKNOWN DATE, THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION, WHICH THE SURGEON ATTRIBUTED TO THE SURGICAL DELAY. TO ADDRESS THE INFECTION, THE X-CORE IMPLANT WAS REMOVED AND REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15341100 ↗
• InjurySep 1, 2022Positioning Failure; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Positioning Failure; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  DURING A VERTEBRAL BODY REPLACEMENT PROCEDURE AT L2 WITH THE X-CORE 2 SYSTEM, THE GEAR RETAINER RING OF THE X-CORE INSERTER WAS REPORTED TO BE LOOSE AND THE SURGEON HAD DIFFICULTY FULLY ENGAGING THE INSERTER WITH THE X-CORE IMPLANT. DURING THE PROCEDURE, AN INITIAL X-CORE IMPLANT WAS INSERTED INTO L2 BUT IT COULD NOT BE EXPANDED. TWO MORE X-CORE IMPLANTS WERE ATTEMPTED BUT SIMILAR PROBLEMS WERE ENCOUNTERED AFTER INSERTION INTO L2. A FOURTH X-CORE IMPLANT WAS USED AND SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT THE IMPLANTATION ISSUES DELAYED THE SURGERY BY APPROXIMATELY THREE HOURS. NO PATIENT INJURY OR CONSEQUENCE OCCURRED DURING THE PROCEDURE OR IMMEDIATELY POST-OP. HOWEVER, ON A SUBSEQUENT, UNKNOWN DATE, THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION, WHICH THE SURGEON ATTRIBUTED TO THE SURGICAL DELAY. TO ADDRESS THE INFECTION, THE X-CORE IMPLANT WAS REMOVED AND REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15341006 ↗
• InjuryAug 12, 2021Overcorrection; Activation Failure; Overcorrection; Activation Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL CORPECTOMY PROCEDURE AT L2. DURING THE PROCEDURE, THE SURGEON ATTACHED THE EXPANDING VERTEBRAL BODY REPLACEMENT IMPLANT TO THE INSERTER AND ATTEMPTED TO BEGIN THE EXPANSION OPERATION; HOWEVER, THE IMPLANT WAS UNABLE TO BE EXPANDED. THERE WERE NO REPLACEMENT IMPLANTS OF THE SAME SIZE AVAILABLE. THEREFORE, THE SURGEON OPTED TO USE AN IMPLANT OF THE NEXT SIZE UP. UPON INSERTION OF THE IMPLANT INTO THE L2 SPACE, IT WAS NOTED THAT FRACTURES OF UPPER AND LOWER ENDPLATES OF THE ADJACENT VERTEBRAL BODIES OCCURRED. THE IMPLANT WAS PLACED AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bone Fracture(s); Vertebral Fracture

  MAUDE report 12315657 ↗