MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN TAPERED IMPLANT HEALING ABUTMENT 5 MMH-5.0 IMPLANT

Model Number 70-1153-IMP0011

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

The dentist reported that healing abutments were not engaging the implants properly.It was stated by the doctor that upon closer inspection the threading on the healing abutments looked different form the cove screw.The actual complaint part is yet to be received for investigation.More results will be available upon completion of the investigation.However, the patient is reported to be in satisfactory condition and no adverse events were reported.

Event Description

The doctor advised that the component ( healing abutments ) were not engaging with the implants.The doctor used another hand piece that did engage correctly.An update was received on 1/25/2017.The doctor attempted to place a healing abutment on (b)(6) 2017 at tooth location #13.During the attempt the doctor observed that the healing abutment was not engaging the implant correctly.No adverse events were reported.

Manufacturer Narrative

The device has not been returned.However, a nonvisual investigation has been completed and the results are as follows: device history record (dhr) reviewed results: lot number was not provided.Stock product reviewed.Results: complaint could not be verified.Returned sample(s)/device inspected results: no product was returned.Investigation results: complaint could not be verified.Root cause: complaint could not be verified.

• Brand Name: HAHN TAPERED IMPLANT HEALING ABUTMENT 5 MMH-5.0 IMPLANT
• Type of Device: ABUTMENT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 6336727
• MDR Text Key: 67946517
• Report Number: 3002195199-2017-00015
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K143353
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 70-1153-IMP0011
• Device Catalogue Number: 70-1153-IMP0011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 73