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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a promark apex locator gave incorrect measurements.It was initial reported that no measurement was possible with promark apex locator.However, on the accompanying letter that was enclosed with the device when it was sent in for investigation, the customer stated ¿incorrect measurement¿.
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 21cfr part 803.Investigation results: investigation result received from external service center emsar: approved not reading lengths correctly.Dentsply promark apex locator sn:(b)(6) accessories: 1 x measuring cable 1 x clip.Evaluation: was not able to duplicate issue.Unit is in good/clean condition with no visible damages.Tested unit with the promark tester and tested the measuring cables that came with the unit.Both tests passed.Touchscreen checks ok.Sound checks ok.Tested apex locator function with the apex fixture.Was able to detect all 3 levels of the apex; test passed.Moved the cable around while checking apex and no loss of connection.Battery checks ok.Possibly bad prong on micro-usb for the measuring cable causing bad connection.Recommend: 1 x v841119000506, 1 x v841119000515.Conclusion: no fault found.Recommended as precautionary measure is to replace the file clip + measurement cable.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

• 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: 24019537
• Report Number: 9611053-2026-00006
• Device Sequence Number: 10550114
• Product Code: LQY
• UDI-Device Identifier: E225V8411130000001
• UDI-Public: E225V8411130000001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 01/09/2026

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: 01/05/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown