MAUDE Adverse Event Report: KERR CORPORATION MAXCEM ELITE; CEMENT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Sensitivity of Teeth (2427)

Event Type  Injury  

Manufacturer Narrative

No patient information was provided in regards to age, weight, ethnicity, and race.The date of event was reported as being in the last ten months, specific date not provided.Device manufacture date cannot be determined because there was not lot number provided.The product was not returned and there was no lot number or part number provided, therefore no evaluation can be conducted.

Event Description

A complainant alleged that one (1) patient had to get a root canal done after multiple debondings and cementations caused sensitivity.

Manufacturer Narrative

Awareness date was corrected.

• Brand Name: MAXCEM ELITE
• Type of Device: CEMENT
• Manufacturer (Section D): KERR CORPORATION; 1717 w.collins avenue; orange CA 92867
• Manufacturer (Section G): KAVO KERR; 1717 w collins avenue; orange CA 92867
• Manufacturer Contact: paulo calle ; 1717 w collins avenue; orange, CA 92867
• MDR Report Key: 7805122
• MDR Text Key: 117869065
• Report Number: 2024312-2018-00001
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

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: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 07/23/2018
• Supplement Dates FDA Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention