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

Model Number UNKNOWN

Device Problems Device-Device Incompatibility (2919); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Anxiety (2328); Depression (2361); Osteopenia/ Osteoporosis (2651); Tissue Breakdown (2681); No Code Available (3191)

Event Type  Injury  

Event Description

Patient email alleges that her oral surgeon misrepresented the products they were implanting.

• Brand Name: UNKNOWN
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: james tilllman ; 3050 e hillcrest drive; thousand oaks, CA 91362 ; 2152648307
• MDR Report Key: 7452484
• MDR Text Key: 106221813
• Report Number: 3001617766-2018-00070
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2018

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
• Device Operator: Dentist
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability