MAUDE Adverse Event Report: PREMIER DENTAL PRODUCTS COMPANY ZR-CEM; DENTAL CEMENT

Catalog Number 3001562

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 06/15/2022

Event Type  Injury  

Manufacturer Narrative

Dr.(b)(6) was contacted by dr.(b)(6) and zr-cem was used incorrectly which led to the crown not being cemented properly.

Event Description

Dentist misused zr cem in cementing a crown resulting in the crown coming off and becoming swallowed by the patient.

• Brand Name: ZR-CEM
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): PREMIER DENTAL PRODUCTS COMPANY; 1710 romano drive; plymouth meeting PA 19462
• Manufacturer (Section G): B.J.M. LABORATORIES LTD; 12 hassadna st; industrial park, or-yehuda central 60220 11; IS 6022011
• Manufacturer Contact: jessica huang ; 1710 romano drive; plymouth meeting, PA 19462 ; 6102396000
• MDR Report Key: 15093456
• MDR Text Key: 296477825
• Report Number: 2511556-2022-00003
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150601
• 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: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 3001562
• Device Lot Number: 5118-13HQBSECRPISTR
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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
• Patient Outcome(s): Other