MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELZYGOMA 0° 47.5MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	38281
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The implant malfunctioned due to dropping from the implant driver.The malfunction did not cause or contribute to a death or serious injury.

• Brand Name: NOBELZYGOMA 0° 47.5MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 16297590
• Report Number: 2027971-2023-037428
• Device Sequence Number: 17629631
• Product Code: DZE
• UDI-Device Identifier: 07332747161526
• UDI-Public: (01)07332747161526(10)12163102(17)251002
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 02/03/2023

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: 10/02/2025
• Device Model Number: 38281
• Device Catalogue Number: 38281
• Device Lot Number: 12163102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/23/2023
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/03/2023