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

Catalog Number 6530-15N

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Per complaint (b)(4), the healing collar was not completely anodized and that there was a random pattern of dots on it.

Manufacturer Narrative

Follow-up submitted to report device status.Product was not received for evaluation.A lot check was requested on 1/10/19.There was no remaining inventory and there are no other complaints regarding this issue.A query was completed in our database and it was determined that this event is remote but possible to occur with a probability of occurrence that is less than 0.1%.Additionally, it was determined that there is no risk to patient as anodizing does not affect form, fit or function.This complaint cannot be confirmed and there is no further action at this time.

• Brand Name: INTERACTIVE HEALING COLLAR NARROW
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT MANUFACTURING LLC; 3050 east hillcrest dr.; thousand oaks CA 91362
• MDR Report Key: 8215601
• MDR Text Key: 132084026
• Report Number: 3001617766-2019-00007
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307109914
• UDI-Public: 10841307109914
• 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: 03/22/2019

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: Health Professional
• Device Expiration Date: 10/10/2023
• Device Catalogue Number: 6530-15N
• Device Lot Number: 125215
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 03/22/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1