MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACT LEGACY2 SBM IMPLANT 7.0DX06L 5.7MMD PLAT; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	827006
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	06/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Japan 510k # 22700bzi00018000.
Event or Problem Description
Failure to osseointegrate.

• Brand Name: LEGACY2 SBM IMPLANT 7.0DX06L 5.7MMD 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: sergio alvarado ; 3050 east hillcrest drive; thousand oaks 91362 ; 8057785975
• MDR Report Key: 20444597
• Report Number: 3001617766-2024-008820
• Device Sequence Number: 8213423
• Product Code: DZE
• UDI-Device Identifier: 10841307101536
• UDI-Public: (01)10841307101536(10)15007140(17)280601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: JAPAN IN H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial

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: 827006
• Device Lot Number: 15007140
• 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
• Initial Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2023
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 70 KG