MAUDE Adverse Event Report: IMPLANT DIRECT LLC LEGACY1 IMPLANT; DENTAL IMPLANT

Model Number	804213
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Granuloma (1876); Failure of Implant (1924)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's identifier was not provided.If the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.
Event or Problem Description
Per complaint (b)(4), after clinical procedure, patient experienced failure of implant to osseointegrate.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Device received is different from the part that was indicated on the initial 3500a report.Lot number and manufacture/expiration dates previously submitted do not apply.

• Brand Name: LEGACY1 IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT LLC; 27030 malibu hills rd.; calabasas hills CA 91301
• Manufacturer Contact: karen manalili ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785914
• MDR Report Key: 13389826
• Report Number: 3001617766-2022-00370
• Device Sequence Number: 14527039
• Product Code: DZE
• UDI-Device Identifier: 10841307100867
• UDI-Public: 10841307100867
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K061319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022

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 Model Number: 804213
• Device Catalogue Number: 804213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 01/29/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 77 KG