MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE 3.2MMDX10MML SBM 3.0MMD PLATFORM; DENTAL IMPLANT

Model Number 653210

Device Problem Device-Device Incompatibility (2919)

Patient Problem Failure of Implant (1924)

Event Date 10/27/2017

Event Type  malfunction  

Event Description

Per complaint# (b)(4), complainant reports she was unable to remove fixture mount during procedure.

• Brand Name: INTERACTIVE 3.2MMDX10MML SBM 3.0MMD PLATFORM
• 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: crystal barczi ; 3050 e hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7290611
• MDR Text Key: 100935048
• Report Number: 3001617766-2018-00024
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307100331
• UDI-Public: 10841307100331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 05/26/2022
• Device Model Number: 653210
• Device Catalogue Number: 653210
• Device Lot Number: 95567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2017
• 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