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

Catalog Number	925710
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Granuloma (1876); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Osteopenia/ Osteoporosis (2651); Fibrosis (3167)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age is unknown.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.Pma/510(k) - not applicable.
Event or Problem Description
Per complaint (b)(4), after clinical procedure, patient experienced failure of implant to osseointegrate.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated section for report submission date and to report device evaluation results.Updated for device return date, follow-up report submitter, awareness date and report type and follow-up number.Updated follow-up type, device evaluation status and method, result and conclusion codes.

• Brand Name: SWISHPLUS 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: 12438130
• Report Number: 3001617766-2021-05261
• Device Sequence Number: 19746617
• Product Code: DZE
• UDI-Device Identifier: 10841307106302
• UDI-Public: 10841307106302
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 11/12/2021

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: 10/11/2020
• Device Catalogue Number: 925710
• Device Lot Number: 68895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 11/06/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2015
• 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 Sex: Male
• Patient Weight: 79 KG