MAUDE Adverse Event Report: KURARAY NORITAKE DENTAL INC. KATANA ZIRCONIA STML A3.5 COLLAR; ZIRCONIA DISC

Catalog Number 125-3223KA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tooth Fracture (2428)

Event Date 05/30/2017

Event Type  Injury  

Event Description

Patient had a zirconia bridge (#29-31) seated in the mouth on (b)(6) 2017 by a dental professional.It was created by a lab in mo.Pontic (#30) and abutment (#31) fractured; causing tooth #29 to fracture at the gumline on (b)(6) 2017.Tooth #29 cannot be saved, and the patient has been recommended to receive treatment for an implant and implant retained bridge, in order to replace the failed bridge.The patient has the remaining portion of the bridge (#31) still in his mouth.The lab feels that the fabrication of the bridge did not contribute to this event.The lab contacted the dealer who sold the product to report this incident, and would like to have the zirconia material evaluated for potential defect.

• Brand Name: KATANA ZIRCONIA STML A3.5 COLLAR
• Type of Device: ZIRCONIA DISC
• Manufacturer (Section D): KURARAY NORITAKE DENTAL INC.; 300 higashiyama, miyoshi-cho; miyoshi, aichi 470-0 293; JA 470-0293
• MDR Report Key: 6807124
• MDR Text Key: 83134858
• Report Number: 3002675355-2017-00001
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2017,07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 125-3223KA
• Device Lot Number: DPONL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2017
• Distributor Facility Aware Date: 07/12/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/09/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 70 YR