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

Model Number	754208
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994); Osteopenia/ Osteoporosis (2651); Fibrosis (3167)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
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 b4 for report submission date and b6 to report device evaluation results.Updated d4 for catalog # and unique identifier (udi) #, d9 for device return date, g1 for follow-up report submitter, g3 for awareness date and g6 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.When information becomes available, a supplemental report will be filed.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.

• Brand Name: REACTIVE IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 9762300
• Report Number: 3001617766-2020-01956
• Device Sequence Number: 16841008
• Product Code: DZE
• UDI-Device Identifier: 10841307103639
• UDI-Public: 10841307103639
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• 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): 10/29/2020

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: 01/15/2023
• Device Model Number: 754208
• Device Catalogue Number: 753710
• Device Lot Number: 107289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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