MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISHACTIVE IMPLANT; DENTAL IMPLANT

Catalog Number	944810
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Granuloma (1876); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Osteopenia/ Osteoporosis (2651); Fibrosis (3167)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight was not provided.If the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.
Event or Problem Description
Per complaint (b)(6), after clinical procedure, patient experienced failure of implant to osseointegrate.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.

• Brand Name: SWISHACTIVE IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: karen manalili ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785914
• MDR Report Key: 13288299
• Report Number: 3001617766-2022-00198
• Device Sequence Number: 19972235
• Product Code: DZE
• UDI-Device Identifier: 10841307106722
• UDI-Public: 10841307106722
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K130572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 03/17/2025
• Device Catalogue Number: 944810
• Device Lot Number: 162724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2020
• 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: 32 YR
• Patient Sex: Female