MAUDE Adverse Event Report: NOBEL BIOCARE USA INC NOBELREPLACE CC PMC NP 3.5X16MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	37289
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to a loss of osseointegration.

• Brand Name: NOBELREPLACE CC PMC NP 3.5X16MM
• 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: 18227869
• Report Number: 2027971-2023-147221
• Device Sequence Number: 20388908
• Product Code: DZE
• UDI-Device Identifier: 07332747073607
• UDI-Public: (01)07332747073607(10)13058677(17)221227
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K062566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• 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: 12/27/2022
• Device Catalogue Number: 37289
• Device Lot Number: 13058677
• 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: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2018
• 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: 71 YR
• Patient Sex: Female