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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY VDW GMBH PROMARK APEX LOCATOR; LOCATOR, ROOT APEX
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DENTSPLY VDW GMBH PROMARK APEX LOCATOR; LOCATOR, ROOT APEX Back to Search Results
Catalog Number PMKAL1
Medical Device Problem Code Incorrect Measurement (1383)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
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 21cfr part 803.Evaluation found the battery needed replaced.
 
Event or Problem Description
In this event it was reported that a promark apex locator will not show file progressing in the canal, and no beeps (incorrect measurement); no injury occurred.
 
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Brand Name
PROMARK APEX LOCATOR
Common Device Name
LOCATOR, ROOT APEX
Manufacturer (Section D)
DENTSPLY VDW GMBH
bayerwaldstrasse 15
munich, 81737
GM  81737
MDR Report Key8438908
Report Number9611053-2019-00053
Device Sequence Number1987302
Product Code LQY
Combination Product (Y/N)N
PMA/510(K) Number
K131907
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Type of Report Initial
Report Date (Section B) 03/20/2019
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
Operator of Device Health Professional
Device Catalogue NumberPMKAL1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/18/2019
Initial Report FDA Received Date03/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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