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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: X-NAV TECHNOLOGIES, LLC X-GUIDE X-MARK PROBE TOOL; DENTAL SURGICAL NAVIGATION DEVICE
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X-NAV TECHNOLOGIES, LLC X-GUIDE X-MARK PROBE TOOL; DENTAL SURGICAL NAVIGATION DEVICE Back to Search Results
Model Number P010673
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Insufficient Information (4580)
Event Date 10/05/2021
Event Type  malfunction  
Event Description
The doctor's probe tool tip became loose during oral surgery while he was registering points in the patient's mouth for the x-mark process.The doctor was able to retrieve the tip before it fell into the patient's mouth.
 
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Brand Name
X-GUIDE X-MARK PROBE TOOL
Type of Device
DENTAL SURGICAL NAVIGATION DEVICE
Manufacturer (Section D)
X-NAV TECHNOLOGIES, LLC
1555 bustard road
suite 75
lansdale PA 19446
Manufacturer (Section G)
X-NAV TECHNOLOGIES, LLC
1555 bustard road
suite 75
lansdale PA 19446
Manufacturer Contact
kimberly chan
1555 bustard road
suite 75
lansdale, PA 19446
2674360420
MDR Report Key12722350
MDR Text Key280938605
Report Number3011764595-2021-00001
Device Sequence Number1
Product Code PLV
UDI-Device Identifier00817421020995
UDI-Public00817421020995
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Remedial Action Replace
Type of Report Initial
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP010673
Device Lot Number2007010010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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