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

Model Number	37610
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed because primary stability could not be achieved.

• 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
• 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: 16889290
• Report Number: 9611993-2023-064909
• Device Sequence Number: 14993234
• Product Code: DZE
• UDI-Device Identifier: 07332747086270
• UDI-Public: (01)07332747086270(10)12096130(17)220921
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K050406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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 Expiration Date: 09/21/2022
• Device Model Number: 37610
• Device Catalogue Number: 37610
• Device Lot Number: 12096130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• 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: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2017
• 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: 67 YR
• Patient Sex: Unknown