MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACT LEGACY2 SBM IMPLANT 4.2DX08L 3.5MMD PLAT; ENDOSSEOUS DENTAL IMPLANT

Catalog Number 824208

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 11/02/2023

Event Type  Injury  

Event Description

Other product deficiencies and technical.

• Brand Name: LEGACY2 SBM IMPLANT 4.2DX08L 3.5MMD PLAT
• 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: 18413073
• MDR Text Key: 331545879
• Report Number: 3001617766-2023-005462
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307101307
• UDI-Public: (01)10841307101307(10)15001202(17)271102
• 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
• 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 Catalogue Number: 824208
• Device Lot Number: 15001202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 200 KG