MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACT SWISHACTIVE IMPLANT 4.8MMD 8MML; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	944808
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Granuloma (1876); Failure of Implant (1924)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration with granulated tissue found around implant and biomechanical overload described.

• Brand Name: SWISHACTIVE IMPLANT 4.8MMD 8MML
• 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 ; 805778
• MDR Report Key: 18153139
• Report Number: 3001617766-2023-005087
• Device Sequence Number: 18140641
• Product Code: DZE
• UDI-Device Identifier: 10841307106715
• UDI-Public: (01)10841307106715(10)152179(17)241019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• 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 Expiration Date: 10/19/2024
• Device Catalogue Number: 944808
• Device Lot Number: 152179
• 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: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2019
• 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: 38 YR
• Patient Sex: Male
• Patient Weight: 190 KG