MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACT LEGACY3 SBM IMPLANT 5.2DX08L 4.5MMD PLA; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	855208
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.
Additional Manufacturer Narrative
Date of event updated to 12/2/2024.
Event or Problem Description
Failure to osseointegrate.

• Brand Name: LEGACY3 SBM IMPLANT 5.2DX08L 4.5MMD PLA
• Common Device Name: 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 ; 8057785975
• MDR Report Key: 21073019
• Report Number: 3001617766-2025-005023
• Device Sequence Number: 12453958
• Product Code: DZE
• UDI-Device Identifier: 10841307102229
• UDI-Public: (01)10841307102229(10)15004010(17)280223
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup

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 Catalogue Number: 855208
• Device Lot Number: 15004010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2023
• 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: 63 YR
• Patient Sex: Female