MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY IMPLANT TRANSFER; DENTAL IMPLANT

Catalog Number 8045-05

Device Problem Osseointegration Problem (3003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Per complaint (b)(4), during clinical procedure, components could not be separated.

Manufacturer Narrative

Patient weight is unknown.Implant and explant dates are not provided.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

• Brand Name: LEGACY IMPLANT TRANSFER
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: karen manalili ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785914
• MDR Report Key: 14546119
• MDR Text Key: 292954158
• Report Number: 3001617766-2022-02804
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307121428
• UDI-Public: 10841307121428
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8045-05
• Device Lot Number: 196557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2021
• 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
• Patient Sex: Male