MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG HEALING ABUTMENT CC RP Ø6X5MM

Catalog Number	36648
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had accidentally swallowed the abutment and was hospitalized after.

• Brand Name: HEALING ABUTMENT CC RP Ø6X5MM
• Common Device Name: ABUTMENT
• 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 ; popeweg 72; venlo 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 22513655
• Report Number: 9611993-2025-104219
• Device Sequence Number: 8736933
• Product Code: DZE
• UDI-Device Identifier: 07332747034424
• UDI-Public: (01)07332747034424(10)13185639(17)280105
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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

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: 36648
• Device Lot Number: 13185639
• Was Device Available for Evaluation?: No
• 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: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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: Hospitalization
• Patient Age: 34 YR
• Patient Sex: Female