MAUDE Adverse Event Report: Nobel Biocare AB Göteborg NOBELREPLACE® Tapered Groovy RP 4.3x10mm; Endosseous Dental Implant

Catalog Number	32216
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury

• Brand Name: NOBELREPLACE® Tapered Groovy RP 4.3x10mm
• 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: 50954264
• Report Number: 9611993-2026-136729
• Device Sequence Number: 18547745
• Product Code: DZE
• UDI-Device Identifier: 07332747001846
• UDI-Public: (01)07332747001846(10)13058468(17)221221
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 12/21/2022
• Device Catalogue Number: 32216
• Device Lot Number: 13058468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2018
• 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: Female