MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELACTIVE WP 5.5X10MM; ENDOSSEOUS DENTAL IMPLANT

Model Number 37808

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 11/01/2022

Event Type  Injury  

Event Description

Implant failed due to part not functional.

• Brand Name: NOBELACTIVE WP 5.5X10MM
• Type of Device: 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: 16726740
• MDR Text Key: 313157340
• Report Number: 9611993-2023-057488
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07332747088373
• UDI-Public: (01)07332747088373(10)12141974(17)240824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133731
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37808
• Device Catalogue Number: 37808
• Device Lot Number: 12141974
• 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?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2019
• 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: 61 YR
• Patient Sex: Male