MAUDE Adverse Event Report: DENTSPLY LLC PALODENT PLUS UNIV 2 RING REF; INSTRUMENTS, DENTAL HAND

Catalog Number 659760

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/16/2023

Event Type  malfunction  

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, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it is reported that palodent plus univ 2 ring ref broke during use.The outcome of this event is unknown as of this mdr.

Manufacturer Narrative

The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.Because the return was not received and the customer did not provide a lot number, no investigation could be completed.

• Brand Name: PALODENT PLUS UNIV 2 RING REF
• 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: 17974502
• MDR Text Key: 326146581
• Report Number: 2515379-2023-00104
• Device Sequence Number: 1
• Product Code: DZN
• UDI-Device Identifier: D0026597601
• UDI-Public: D0026597601
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 659760
• Device Lot Number: 550809
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/16/2023
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1