FDA Adverse Event
Malfunction
Summary report: N
X-GUIDE SURGICAL NAVIGATION SYSTEM
MDR report key: 20673512
·
Received November 13, 2024
Report
- Report Number
- 3011764595-2024-00001
- Event Type
- Malfunction
- Date Received
- November 13, 2024
- Date of Event
- November 8, 2024
- Report Date
- November 12, 2024
- Manufacturer
- X-NAV TECHNOLOGIES, LLC
- Product Code
- QRY
- PMA / PMN Number
- K150222
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DEVICE CURRENTLY UNUSABLE AT DOCTOR'S OFFICE, PENDING SERVICE AND RETURN OF PART TO HEADQUARTERS.
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2481362 | X-GUIDE SURGICAL NAVIGATION SYSTEM | DENTAL SURGICAL NAVIGATION SYSTEM | QRY | X-NAV TECHNOLOGIES, LLC | P007839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Prefer Not To Disclose |