MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELSPEEDY GROOVY NP 3.3X8.5MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	37610
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Failure of Implant (1924)
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: NOBELSPEEDY GROOVY NP 3.3X8.5MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 20229122
• Report Number: 2027971-2024-122910
• Device Sequence Number: 15263933
• Product Code: DZE
• UDI-Device Identifier: 07332747086270
• UDI-Public: (01)07332747086270(10)12141361(17)240815
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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

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: 08/15/2024
• Device Catalogue Number: 37610
• Device Lot Number: 12141361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/30/2024
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2024
• 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