MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 4 IMPLANT; DENTAL IMPLANT

Catalog Number	884213
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Granuloma (1876); Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	05/20/2021
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.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.
Additional Manufacturer Narrative
Follow-up submitted for additional information.Updated section b4 for report submission 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.Patient identifier is unknown this complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.

• Brand Name: LEGACY 4 IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 12083798
• Report Number: 3001617766-2021-03800
• Device Sequence Number: 3464962
• Product Code: DZE
• UDI-Device Identifier: 10841307103332
• UDI-Public: 10841307103332
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K192221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2021

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: 11/24/2024
• Device Catalogue Number: 884213
• Device Lot Number: 153945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 07/09/2021; 07/09/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/16/2021; 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 77