MAUDE Adverse Event Report: NOBEL BIOCARE USA INC NOBELREPLACE CC PMC RP 5.0X11.5MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	37297
Medical Device Problem Codes	Difficult to Insert (1316); Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant malfunctioned due to part/interface does not engage.
Additional Manufacturer Narrative
The initial report did not have the correct event type documented, the correct event type, injury, is provided in this follow up report.
Event or Problem Description
The initial report did not have the correct event type documented, the correct event type, injury, is provided in this follow up report.

• Brand Name: NOBELREPLACE CC PMC RP 5.0X11.5MM
• 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: 18467863
• Report Number: 2027971-2024-030273
• Device Sequence Number: 3087646
• Product Code: DZE
• UDI-Device Identifier: 07332747073522
• UDI-Public: (01)07332747073522(10)13069269(17)230718
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K062566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2023
• Device Catalogue Number: 37297
• Device Lot Number: 13069269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2018
• 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 Sex: Unknown