MAUDE Adverse Event Report: DENTSPLY MAILLEFER PROPEX II APEX LOCATOR; LOCATOR, ROOT APEX

Catalog Number A102800000000

Device Problems Incorrect Measurement (1383); Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 05/07/2015

Event Type  malfunction  

Event Description

In this event it was reported that a propex ii apex locator was giving incorrect measurements; the event outcome is unk as of this mdr evaluation.Additional information has been requested, but is not yet available.

Manufacturer Narrative

While there is no indication that injury resulted, 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 tat are when taking into account composition and indications for use.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Multiple unsuccessful attempts were made no obtain the pt outcome.The device was evaluated and found to be within spec.

• Brand Name: PROPEX II APEX LOCATOR
• Type of Device: LOCATOR, ROOT APEX
• Manufacturer (Section D): DENTSPLY MAILLEFER; ballaigues ; SZ
• Manufacturer Contact: helen lewis ; 221 w philadelphia st, ste. 60; susquehanna commerce center w; york, PA 17401 ; 7178457511
• MDR Report Key: 4843804
• MDR Text Key: 5913805
• Report Number: 8031010-2015-00018
• Device Sequence Number: 1
• Product Code: LQY
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A102800000000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2015
• 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: Unknown
• Patient Sequence Number: 1