MAUDE Adverse Event Report: NOBEL BIOCARE USA INC REPLACE SELECT TAPERED TIU WP 5.0X16MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	29425
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to osseointegration problem.

• Brand Name: REPLACE SELECT TAPERED TIU WP 5.0X16MM
• 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: 19568939
• Report Number: 2027971-2024-093410
• Device Sequence Number: 14987622
• Product Code: DZE
• UDI-Device Identifier: 07332747000184
• UDI-Public: (01)07332747000184(10)441509(17)150409
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K023113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 04/09/2015
• Device Catalogue Number: 29425
• Device Lot Number: 441509
• 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: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2010
• 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 Sex: Unknown