MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC X-TIP INTRAOSSEOUS ANESTHESIA DELIVERY SYSTEM; NEEDLE, DENTAL

Catalog Number XTIP50

Device Problem Break (1069)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of 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.

Event Description

It was reported that an x-tip broke during use on a patient and went vertically through the bone between tooth 18 and 19.The doctor had to surgically remove the broken piece.

Manufacturer Narrative

Customer returned 47 opened drill and guide sleeves in a zip lock bag and 1 broken guide sleeve in an auto clave bag.Using the ansi plan with and aql of 1.5 using normal sample plan randomly selected and tested 8 pieces.Using opt comp - 002 measured 8 guide sleeves.Using drawing number sp-pxtp0005 indicates the specification for the guide sleeve diameter is.635mm -.648mm.

• Brand Name: X-TIP INTRAOSSEOUS ANESTHESIA DELIVERY SYSTEM
• 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: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 7538260
• MDR Text Key: 109061953
• Report Number: 2320721-2018-00045
• 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,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XTIP50
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention