MAUDE Adverse Event Report: VDW GMBH PROMARK APEX LOCATOR; LOCATOR, ROOT APEX

Catalog Number	PMKAL1
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that a promark apex locator gave incorrect measurements and sometimes does not read at all.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
2 unsuccessful requests for product return and investigation result were made.No reply was received from external investigation division.2 (two) unsuccessful requests to retrieve suspect product or investigation result have been made and documented.Complaint will be reopened if suspect product or investigation result arrives per 8000-sop-038.

• Brand Name: PROMARK APEX LOCATOR
• Common Device Name: LOCATOR, ROOT APEX
• Manufacturer (Section D): VDW GMBH; bayerwaldstrasse 15; munich bayern 81737 ; GM 81737
• Manufacturer (Section G): VDW GMBH; bayerwaldstrasse 15; munich bayern 81737 ; GM 81737
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22802878
• Report Number: 9611053-2025-00112
• Device Sequence Number: 7798797
• Product Code: LQY
• UDI-Device Identifier: E225V8411130000001
• UDI-Public: E225V8411130000001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PMKAL1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/06/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown