MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE HEALING COLLAR NARROW; DENTAL IMPLANT

Model Number 6534-15N

Device Problem Failure to Osseointegrate (1863)

Patient Problems Failure of Implant (1924); Fibrosis (3167)

Event Date 10/10/2019

Event Type  Injury  

Event Description

Per complaint (b)(4), after clinical procedure, patient experienced failure of implant to osseointegrate.

Manufacturer Narrative

Updated b4 for report submission date, g1 for contact information, g3 for awareness date of new information, g6 for report type and sections d9, h1, h2, h3, and h6 to report that the device was not received for analysis.Information for section a4 was not available.When information becomes available, a supplemental report will be filed.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.

• Brand Name: INTERACTIVE HEALING COLLAR NARROW
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9320292
• MDR Text Key: 166310745
• Report Number: 3001617766-2019-05103
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307109945
• UDI-Public: 10841307109945
• Combination Product (y/n): N
• PMA/PMN Number: K130572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2024
• Device Model Number: 6534-15N
• Device Catalogue Number: 6534-15N
• Device Lot Number: 135573
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR