MAUDE Adverse Event Report: Nobel Biocare AB Göteborg NobelParallel CC NP 3.75x11.5mm; Endosseous Dental Implant

Catalog Number	37966
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: NobelParallel CC NP 3.75x11.5mm
• Common Device Name: Endosseous Dental Implant
• Manufacturer (Section D): Nobel Biocare AB Göteborg; västra hamngatan 1; göteborg 41117 ; SW 41117
• Manufacturer (Section G): Nobel Biocare AB Göteborg; västra hamngatan 1; göteborg 41117 ; SW 41117
• Manufacturer Contact: gayco meel ; heierkerweg 1b; venlo 5928 -RM ; NL 5928 RM ; +031()623202508
• MDR Report Key: 50061724
• Report Number: 9611993-2026-112262
• Device Sequence Number: 13438126
• Product Code: DZE
• UDI-Device Identifier: 07332747091458
• UDI-Public: (01)07332747091458(10)12086407(17)220416
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: 04/16/2022
• Device Catalogue Number: 37966
• Device Lot Number: 12086407
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2017
• 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: Female