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

Catalog Number	904110
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's identifier and weight were not provided.If the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not applicable since the product was not returned.If product returns, analysis will be completed and a supplemental report will be submitted.
Event or Problem Description
Per complaint (b)(4), patient experienced failure of implant to integrate.
Event or Problem Description
Per complaint (b)(4), patient experienced failure of implant to integrate.
Additional Manufacturer Narrative
Patient's identifier and weight were not provided.If the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not applicable since the product was not returned.If product returns, analysis will be completed and a supplemental report will be submitted.

• Brand Name: SWISHPLANT 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: 13498378
• Report Number: 3001617766-2022-00626
• Device Sequence Number: 17117371
• Product Code: DZE
• UDI-Device Identifier: 10841307105886
• UDI-Public: 10841307105886
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K081396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 02/09/2022

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: 11/19/2013
• Device Catalogue Number: 904110
• Device Lot Number: 19882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2008
• 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: Female