MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACT SIMPLY LEGACY2 SBM IMPLANT 4.2MMD X 8MML; ENDOSSEOUS DENTAL IMPLANT

Catalog Number 824208U

Device Problem No Apparent Adverse Event (3189)

Patient Problem Failure of Implant (1924)

Event Date 10/25/2023

Event Type  Injury  

Event Description

Wrong part used.

• Brand Name: SIMPLY LEGACY2 SBM IMPLANT 4.2MMD X 8MML
• 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: 18321131
• MDR Text Key: 330404952
• Report Number: 3001617766-2023-005328
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307107392
• UDI-Public: (01)10841307107392(10)186256(17)260601
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 824208U
• Device Lot Number: 186256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2021
• 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