MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACT LEGACY2 SBM IMPLANT 3.7DX06L 3.5MMD PLAT; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	823706
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.
Additional Manufacturer Narrative
Injury updated to include "bone loss".
Event or Problem Description
Failure to osseointegrate.

• Brand Name: LEGACY2 SBM IMPLANT 3.7DX06L 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: 25487698
• Report Number: 3001617766-2026-007159
• Device Sequence Number: 15882051
• Product Code: DZE
• UDI-Device Identifier: 10841307101239
• UDI-Public: (01)10841307101239(10)116581(17)230607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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 Expiration Date: 06/07/2023
• Device Catalogue Number: 823706
• Device Lot Number: 116581
• 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: 06/12/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2018
• 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: 53 YR
• Patient Sex: Male