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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY TULSA DENTAL SPECIALTIES PROMARK APEX LOCATOR; LOCATOR, ROOT APEX
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DENTSPLY TULSA DENTAL SPECIALTIES PROMARK APEX LOCATOR; LOCATOR, ROOT APEX Back to Search Results
Catalog Number PMKAL1
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/31/2015
Event Type  malfunction  
Event Description
In this event it was reported that a promark apex locator gave inconsistent measurements; no injury resulted.
 
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.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
 
Manufacturer Narrative
The device was evaluated and found to be within specification.
 
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Brand Name
PROMARK APEX LOCATOR
Type of Device
LOCATOR, ROOT APEX
Manufacturer (Section D)
DENTSPLY TULSA DENTAL SPECIALTIES
johnson city TN
Manufacturer Contact
helen lewis
221 w philadephia st, ste 60
susquehanna commerce ctr w
york, PA 17401
7178457511
MDR Report Key4737402
MDR Text Key5768734
Report Number9611053-2015-00016
Device Sequence Number1
Product Code LQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 03/31/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPMKAL1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2015
Was Device Evaluated by Manufacturer? Yes
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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