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

Model Number	704710
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), during clinical procedure patient experienced failure of implant to integrate.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Section a2, no information was available.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d4 for catalog # and unique identifier (udi) #, d10 for device return date, 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.Device received is different from the part that was indicated on the initial 3500a report.Lot number and manufacture/expiration dates previously submitted do not apply.Lot number information is unknown.This report is submitted late and is captured within capa-1374.

• Brand Name: REPLUS 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: 9207960
• Report Number: 3001617766-2019-04725
• Device Sequence Number: 409576
• Product Code: DZE
• UDI-Device Identifier: 10841307104292
• UDI-Public: 10841307104292
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K073161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: 12/18/2018
• Device Model Number: 704710
• Device Catalogue Number: 704711
• Device Lot Number: 47334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 03/06/2020
• 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