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

Model Number	924810W
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information was not provided and if it becomes available, a follow-up report will be submitted.
Event or Problem Description
Per complaint (b)(4), patient experienced loss or failure of implant to integrate.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d10 for device return date and updated g1-g2 for follow-up report submitter, g4 for awareness date and g7 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.Ni - no information for sections a1-a4 and b7.Device received is different from that which was submitted on the initial 3500a report.Lot number and manufacture/expiration dates previously submitted do not apply.Device returned was not manufactured by our company.

• 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
• MDR Report Key: 9464616
• Report Number: 3001617766-2019-05680
• Device Sequence Number: 14219588
• Product Code: DZE
• UDI-Device Identifier: 10841307106258
• UDI-Public: 10841307106258
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K081396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2020

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: 10/09/2018
• Device Model Number: 924810W
• Device Catalogue Number: 924810W
• Device Lot Number: 45925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention