MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG MULTI-UNIT ABUTMENT XEAL CC RP 3.5MM

Catalog Number	300178
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Foreign particles on the product/in pack.

• Brand Name: MULTI-UNIT ABUTMENT XEAL CC RP 3.5MM
• Common Device Name: ABUTMENT
• Manufacturer (Section D): NOBEL BIOCARE AB GÖTEBORG; bohusgatan 15; göteborg 41139 ; SW 41139
• Manufacturer (Section G): NOBEL BIOCARE AB GÖTEBORG; bohusgatan 15; göteborg 41139 ; SW 41139
• Manufacturer Contact: gayco meel ; popeweg 72; venlo 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 21308880
• Report Number: 9611993-2025-043815
• Device Sequence Number: 8169250
• Product Code: DZE
• UDI-Device Identifier: 07332747188219
• UDI-Public: (01)07332747188219(10)12250027(17)270804
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K202344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 300178
• Device Lot Number: 12250027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2025
• 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: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2024
• 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: Unknown