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

Catalog Number HT2.3LG

Device Problems Fracture (1260); Positioning Problem (3009)

Patient Problem Failure of Implant (1924)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

Patient's age was not provided.When the requested information becomes available, supplementary report will be submitted.Pma/510(k) - not applicable.

Event Description

Per complaint (b)(4), during clinical procedure, product fractured.

• Brand Name: SIMPLYINTERACTIVE DRIVER
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: douglas wilkin ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 6614818356
• MDR Report Key: 10828230
• MDR Text Key: 215881351
• Report Number: 3001617766-2020-07911
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119838
• UDI-Public: 10841307119838
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/12/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2024
• Device Catalogue Number: HT2.3LG
• Device Lot Number: 138488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2019
• 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
• Patient Weight: 93