MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACT LEGACY2 SBM IMPLANT 4.2DX11L 3.5MMD PLAT; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	824211
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.
Event or Problem Description
Failure to osseointegrate.
Additional Manufacturer Narrative
Upon inspection part found to be part # 824211.Part number has been updated in this follow up.

• Brand Name: LEGACY2 SBM IMPLANT 4.2DX11L 3.5MMD PLAT
• 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: anitha mechery ; 3050 east hillcrest drive; thousand oaks 91362 ; 8057785975
• MDR Report Key: 20509518
• Report Number: 3001617766-2024-008922
• Device Sequence Number: 9088015
• Product Code: DZE
• UDI-Device Identifier: 10841307102861
• UDI-Public: (01)10841307102861(10)222953(17)270726
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K192221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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: 824211
• Device Lot Number: 222953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2022
• 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: 70 YR
• Patient Sex: Male