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

Catalog Number	6530-15N
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), the healing collar was not completely anodized and that there was a random pattern of dots on it.
Additional 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
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT MANUFACTURING LLC; 3050 east hillcrest dr.; thousand oaks CA 91362
• MDR Report Key: 8215601
• Report Number: 3001617766-2019-00007
• Device Sequence Number: 19377951
• Product Code: NHA
• UDI-Device Identifier: 10841307109914
• UDI-Public: 10841307109914
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1