MAUDE Adverse Event Report: NOBEL BIOCARE USA INC NOBELACTIVE INTERNAL RP 5.0X10MM; ENDOSSEOUS DENTAL IMPLANT

Model Number 34137

Device Problem Defective Device (2588)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 02/20/2023

Event Type  malfunction  

Event Description

Implant failed due to "part/interface does not fit/align".

• Brand Name: NOBELACTIVE INTERNAL RP 5.0X10MM
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE USA INC; 22725 savi ranch; yorba linda CA 92887 4609
• Manufacturer (Section G): NOBEL BIOCARE USA INC; 22725 savi ranch; yorba linda CA 92887 4609
• Manufacturer Contact: gayco meel ; popeweg 72; venlo 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 16726902
• MDR Text Key: 313158376
• Report Number: 2027971-2023-062994
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07332747160109
• UDI-Public: (01)07332747160109(10)13134541(17)270529
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• 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
• Device Operator: Health Professional
• Device Model Number: 34137
• Device Catalogue Number: 34137
• Device Lot Number: 13134541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female