MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. CLINICAL SCAN. ABUT., POST., COMPATIBLE WITH: BRÅNEMARK SYSTEM RP; CLINICAL SCANNING ABUTMENT

Model Number 70-1049-COM0067

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Device history record review: not able to review the dhr since customer did not provide the lot number.The root cause cannot be explicitly determined.Customer did not return the device for investigation.Customer did not provide the lot number information for review.In addition, it is unknown customer used incorrect components with other third party compatible or followed the protocol/manual correctly.

Event Description

It was reported that the scanning abutment will not screw down all the way.

• Brand Name: CLINICAL SCAN. ABUT., POST., COMPATIBLE WITH: BRÅNEMARK SYSTEM RP
• Type of Device: CLINICAL SCANNING ABUTMENT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2212 dupont dr; suite p; irvine CA 92612
• Manufacturer Contact: herbert schoenhoefer ; 2212 dupont drive; suite p; irvine, CA 92612 ; 9494402632
• MDR Report Key: 8898454
• MDR Text Key: 167370209
• Report Number: 3011649314-2017-00502
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/15/2019

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 Model Number: 70-1049-COM0067
• Device Catalogue Number: 70-1049-COM0067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2017
• Initial Date FDA Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: No
• 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