MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC XTIP:50 MFNA; NEEDLE, DENTAL

Model Number XTIP50

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/05/2023

Event Type  malfunction  

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are: nothing unusual to report was found during dhr review.A query indicates no additional complaints have been received for this lot number.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.

Event Description

In this event it is reported that xtip:50 mfna broke during use.The broken part remains in the patient's mouth.The outcome of this event is unknown as of this mdr.Further information requested.

• Brand Name: XTIP:50 MFNA
• Type of Device: NEEDLE, DENTAL
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17281353
• MDR Text Key: 319282777
• Report Number: 2320721-2023-00262
• Device Sequence Number: 1
• Product Code: DZM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: XTIP50
• Device Catalogue Number: XTIP50
• Device Lot Number: 0000327158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/07/2023
• Date Manufacturer Received: 07/07/2023
• Type of Device Usage: A
• Patient Sequence Number: 1