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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, 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.Additional information: new cables being sent as a courtesy at no charge since there is no history of cables being purchased.
Event or Problem Description
In this event it is reported that a promark apex locator gave incorrect measurements.No injury.
Additional Manufacturer Narrative
After 2 requests, we received the information from the investigation division that no product has been returned - therefore no investigation was possible.Unsuccessful attempts to retrieve suspect product for investigation/evaluation have been made and documented.Complaint will be reopened if suspect product or investigation result arrives per (b)(4).

• 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: 23728151
• Report Number: 9611053-2025-00171
• Device Sequence Number: 16046281
• Product Code: LQY
• UDI-Device Identifier: E225V8411130000001
• UDI-Public: E225V8411130000001
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 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: 11/25/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2025
• Supplement 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