MAUDE Adverse Event Report: DENTSPLY LLC PALODENT V3 NARROW 2 RING REFL; INSTRUMENTS, DENTAL HAND

Catalog Number 659770V

Device Problems Break (1069); Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

In this event it was reported that a palodent plus matrix ring broke during use; no injury resulted.While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, this event meets the criteria for reportability per 21 cfr 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.

Event Description

It was reported that palodent v3 narrow 2 ring broke.The patient was not injured; it was possible to remove all broken parts from the patient's mouth.

Manufacturer Narrative

The device was evaluated and found to be broken as indicated in the complaint.

• Brand Name: PALODENT V3 NARROW 2 RING REFL
• Type of Device: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 12848564
• MDR Text Key: 286115795
• Report Number: 2515379-2021-00025
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

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: 659770V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/05/2021
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1