MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELREPLACE® TAPERED GROOVY WP 5X13MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	32221
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to implant fracture after delivery.

• Brand Name: NOBELREPLACE® TAPERED GROOVY WP 5X13MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 13401435
• Report Number: 2027971-2022-036469
• Device Sequence Number: 1521425
• Product Code: DZE
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 01/31/2022

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: 32221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2022
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2022
• 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 Age: 70 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/31/2022