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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY MAILLEFER PROPEX II APEX LOCATOR; LOCATOR, ROOT APEX
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DENTSPLY MAILLEFER PROPEX II APEX LOCATOR; LOCATOR, ROOT APEX Back to Search Results
Catalog Number A102800000000
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.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by (b)(4).Line breakage inside the file clip and the plug of th measuring cable, contact error.
 
Event or Problem Description
In this event it was reported that a propex ii apex locator was giving incorrect measurements; no injury resulted.
 
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Brand Name
PROPEX II APEX LOCATOR
Common Device Name
LOCATOR, ROOT APEX
Manufacturer (Section D)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ  1338
MDR Report Key8395871
Report Number8031010-2019-00013
Device Sequence Number14435167
Product Code LQY
Combination Product (Y/N)N
PMA/510(K) Number
NA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Type of Report Initial
Report Date (Section B) 03/06/2019
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 NumberA102800000000
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/04/2019
Initial Report FDA Received Date03/06/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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