MAUDE Adverse Event Report: NOBEL BIOCARE USA INC REPLACE SELECT TAPERED TIU WP 5.0X13MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	29424
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to part fractured.

• Brand Name: REPLACE SELECT TAPERED TIU WP 5.0X13MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE USA INC; 22725 savi ranch; yorba linda CA 92887 4609
• Manufacturer (Section G): NOBEL BIOCARE USA INC; 22725 savi ranch; yorba linda CA 92887 4609
• Manufacturer Contact: gayco meel ; popeweg 72; venlo 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 19615346
• Report Number: 2027971-2024-095913
• Device Sequence Number: 12311344
• Product Code: DZE
• UDI-Device Identifier: 07332747000177
• UDI-Public: (01)07332747000177(10)13034176(17)210701
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: 29424
• Device Lot Number: 13034176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male