MAUDE Adverse Event Report: NOBEL BIOCARE USA INC NOBELREPLACE CC PMC RP 5.0X16MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	37299
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to a failure to osseointegrate.

• Brand Name: NOBELREPLACE CC PMC RP 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: 16197100
• Report Number: 2027971-2023-033488
• Device Sequence Number: 5807349
• Product Code: DZE
• UDI-Device Identifier: 07332747073508
• UDI-Public: (01)07332747073508(10)13031591(17)210415
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K062566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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: 04/15/2021
• Device Model Number: 37299
• Device Catalogue Number: 37299
• Device Lot Number: 13031591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2023
• 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: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2016
• 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: 46 YR
• Patient Sex: Female