MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACT LEGACY4 SBM 4.2MMDX8MML 3.5MMD PLAT; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	874208
Medical Device Problem Codes	Positioning Failure (1158); Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Granuloma (1876); Inadequate Osseointegration (2646)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary stability couldn¿t be achieve.
Event or Problem Description
Failure to osseointegrate.

• Brand Name: LEGACY4 SBM 4.2MMDX8MML 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: 23784011
• Report Number: 3001617766-2025-009366
• Device Sequence Number: 15981721
• Product Code: DZE
• UDI-Device Identifier: 10841307102908
• UDI-Public: (01)10841307102908(10)15014465(17)290126
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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: 874208
• Device Lot Number: 15014465
• 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: 12/11/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2024
• 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: 54 YR
• Patient Sex: Male