MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYFIXED INTERACTIVE ANGLED; DENTAL IMPLANT

Catalog Number 6530-62-15SK

Device Problem Osseointegration Problem (3003)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Osteopenia/ Osteoporosis (2651)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

Exemption # e2012017.Report late due to asr to individual reporting transition.

Event Description

Per complaint (b)(4), during post operative check, patient experienced loss or failure of implant to integrate.

• Brand Name: SIMPLYFIXED INTERACTIVE ANGLED
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 8979694
• MDR Text Key: 157102640
• Report Number: 3001617766-2019-01463
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307117629
• UDI-Public: 10841307117629
• 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
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2020
• Device Catalogue Number: 6530-62-15SK
• Device Lot Number: 68388
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2015
• 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 Age: 53 YR