MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELSPEEDY GROOVY WP 6X10MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	32141
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to a failure to osseointegrate.

• Brand Name: NOBELSPEEDY GROOVY WP 6X10MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• Manufacturer (Section G): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• Manufacturer Contact: gayco meel ; popeweg 72; venlo 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 16692542
• Report Number: 9611993-2023-056385
• Device Sequence Number: 5921159
• Product Code: DZE
• UDI-Device Identifier: 07332747159752
• UDI-Public: (01)07332747159752(10)12189869(17)261107
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K050406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 32141
• Device Catalogue Number: 32141
• Device Lot Number: 12189869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• 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: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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: Male