MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY2 IMPLANT; DENTAL IMPLANT

Catalog Number	827010
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), after clinical procedure, patient experienced loss or failure of implant to integrate.
Additional Manufacturer Narrative
The implant failure modes, failure/ loss of osseo-integration and lack of primary stability are not product related and rather are attributed to patient contraindications, conditions, or clinician error in surgical protocol.No product investigation or corrective actions required.Complaints will continue to be trended.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d9 for device return date, g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.

• Brand Name: LEGACY2 IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: marcos gutierrez ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443315
• MDR Report Key: 15093367
• Report Number: 3001617766-2022-03843
• Device Sequence Number: 14742679
• Product Code: DZE
• UDI-Device Identifier: 10841307101550
• UDI-Public: 10841307101550
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2025
• Device Catalogue Number: 827010
• Device Lot Number: 166840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 70 KG