MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELSPEEDY GROOVY RP 4.0X20MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	37611
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Implant failed due to a fracture at delivery.
Event or Problem Description
The initial report did not have the correct event type documented, the correct event type, malfunction, is provided in this follow up report.

• Brand Name: NOBELSPEEDY GROOVY RP 4.0X20MM
• 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: 18907682
• Report Number: 9611993-2024-052762
• Device Sequence Number: 15014636
• Product Code: DZE
• UDI-Device Identifier: 07332747086263
• UDI-Public: (01)07332747086263(10)12070046(17)210715
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K160119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2021
• Device Catalogue Number: 37611
• Device Lot Number: 12070046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2016
• 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: 56 YR
• Patient Sex: Female