MAUDE Adverse Event Report: DENTSPLY LLC 30K SLI-10S INSERT,PACKED; SCALER, ULTRASONIC

Model Number 79611

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

In this event it is reported that a 30k sli-10s insert,packed tip broke during use and was ingested by the patient.The doctor initially told the patient that it would pass but the patient chose to have surgery to have the tip removed.It¿s unclear if the surgery was necessary.

Manufacturer Narrative

There have been previous reports with this or a similar device where this malfunction caused or contributed to a serious injury or required medical/surgical intervention to preclude such.Therefore, this event meets the criteria for a reportable event 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.

Manufacturer Narrative

Adding udi# - udi# (b)(4).This is a follow up report to add this information.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.No investigation could be done.If there is any additional information or results that become available they will be submitted when they become available.This is to correct and remove the codes that were initially reported - removing codes for: health effect - impact code - 2199.The correct codes for this complaint are: health effect - impact code - 4641.

• Brand Name: 30K SLI-10S INSERT,PACKED
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 16532282
• MDR Text Key: 311328187
• Report Number: 2424472-2023-00358
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D003796111
• UDI-Public: D003796111
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052334/K970
• 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: 07/20/2023

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 Model Number: 79611
• Device Catalogue Number: 79611
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/13/2023
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1