inforMED
MalfunctionQRY

X-GUIDE SURGICAL NAVIGATION SYSTEM

Received Nov 13, 2024 · Event occurred Nov 8, 2024

Report 3011764595-2024-00001 · MDR key 20673512

Device

Generic name

Dental Surgical Navigation System

Model number

P007839

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

50 YR · Prefer Not To Disclose

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

OFFICE CALLED AND SAID SOMETHING "SNAPPED" IN ONE THE HINGES WITHIN THE BOOM ARM DURING SURGERY AND THE NAVIGATION ASSEMBLY PARTIALLY DROPPED AND HIT THE DOCTOR. DOCTOR IS PHYSICALLY OKAY. OFFICE WILL CALL BACK WHEN THE MACHINE IS AVAILABLE TO TAKE PICTURES AND ASSESS THE DAMAGE, SO TECHNICAL SUPPORT CAN DETERMINE HOW TO MOVE FORWARD WITH THE REPAIR. CAMERAS AND LIGHTS ARE STILL FUNCTIONAL. PATIENT WAS NOT INVOLVED.

Additional Manufacturer Narrative

DEVICE CURRENTLY UNUSABLE AT DOCTOR'S OFFICE, PENDING SERVICE AND RETURN OF PART TO HEADQUARTERS.