MAUDE Adverse Event Report: Nobel Biocare AB NobelReplace CC RP 4.3x16mm; Endosseous Dental Implant

Catalog Number	36709
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Lack of stability during placement.

• Brand Name: NobelReplace CC RP 4.3x16mm
• Common Device Name: Endosseous Dental Implant
• Manufacturer (Section D): Nobel Biocare AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 50187620
• Report Number: 2027971-2026-115130
• Device Sequence Number: 18643979
• Product Code: DZE
• UDI-Device Identifier: 07332747160543
• UDI-Public: (01)07332747160543(10)13210065(17)310312
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/08/2026
• Report Date (Section F): 08/08/2026

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 Catalogue Number: 36709
• Device Lot Number: 13210065
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/31/2026
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male