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

Catalog Number	754211U
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Burning Sensation (2146); Numbness (2415)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), four days post-op mandible implant placement, the patient presented with burning, inflammation, slight numbness and pain symptoms.The implant was backed out a few millimeters and the doctor followed up the next day and the patient felt better.On (b)(6) 2019, the patient returned into office with continued issues and the implant was extracted.The patient was placed on medrol dose pack post-op implant removal.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated for report submission date and to report device evaluation results.Updated for follow-up report submitter, for awareness date and for report type and follow-up number.Updated for follow-up type, for device evaluation status and method, result and conclusion codes.

• Brand Name: SIMPLY REACTIVE 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: 8363582
• Report Number: 3001617766-2019-00065
• Device Sequence Number: 11261319
• Product Code: DZE
• UDI-Device Identifier: 10841307108108
• UDI-Public: 10841307108108
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2023
• Device Catalogue Number: 754211U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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
• Patient Age: 72 YR