MAUDE Adverse Event Report: Nobel Biocare AB Göteborg NOBELREPLACE® Tapered Groovy RP 4.3x13mm; Endosseous Dental Implant

Catalog Number	32217
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.

• Brand Name: NOBELREPLACE® Tapered Groovy RP 4.3x13mm
• 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: 50332441
• Report Number: 9611993-2026-120894
• Device Sequence Number: 5508142
• Product Code: DZE
• UDI-Device Identifier: 07332747001853
• UDI-Public: (01)07332747001853(10)656120(17)100418
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K050258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2025
• 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): 08/19/2026

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: 04/18/2010
• Device Catalogue Number: 32217
• Device Lot Number: 656120
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2005
• 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: 82 YR
• Patient Sex: Male