MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG NOBELZYGOMA 0° 37.5MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	38277
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The implant malfunctioned due to it fracturing during placement.The malfunction did not cause or contribute to a death or serious injury.
Event or Problem Description
The implant malfunctioned due to it fracturing during placement.The malfunction did not cause or contribute to a death or serious injury.Results of the investigation has concluded in an update that is provided in this follow-up report.
Additional Manufacturer Narrative
Results of the investigation has concluded in an update that is provided in this follow-up report.

• Brand Name: NOBELZYGOMA 0° 37.5MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB GÖTEBORG; bohusgatan 15; göteborg 69151 ; SW 69151
• Manufacturer (Section G): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• Manufacturer Contact: gayco meel ; bohusgatan 15; göteborg 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 19994464
• Report Number: 9611993-2024-099208
• Device Sequence Number: 7075529
• Product Code: DZE
• UDI-Device Identifier: 07332747161489
• UDI-Public: (01)07332747161489(10)12142631(17)240901
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup

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 Expiration Date: 09/01/2024
• Device Catalogue Number: 38277
• Device Lot Number: 12142631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2019
• 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: 68 YR
• Patient Sex: Female