MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACT SIMPLY ICONIC 4.2MMDX11.5MML 3.0MMD P; ENDOSSEOUS DENTAL IMPLANT

Catalog Number 674211NP

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 10/24/2023

Event Type  Injury  

Event Description

Other product deficiencies and technical.

• Brand Name: SIMPLY ICONIC 4.2MMDX11.5MML 3.0MMD P
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACT; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACT; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: sergio alvarado ; 3050 east hillcrest drive; thousand oaks 91362 ; 805778
• MDR Report Key: 18457547
• MDR Text Key: 332216334
• Report Number: 3001617766-2024-005061
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201553
• 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

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 674211NP
• Device Lot Number: 15009594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2023
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 197 KG