MAUDE Adverse Event Report: DENTSPLY LLC CALIBRA CERAM MED REFILL; CEMENT, DENTAL

Catalog Number	607192K
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that calibra ceram med refill possibly caused a patient to have a reaction.The symptoms occurred after treatment were redness, swelling of the papillae and heavy bleeding.Reportedly not injury occurred.
Additional Manufacturer Narrative
As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
Investigation: product will not be returned, lot number unknown, so a dhr investigation cannot be completed.Unsuccessful attempts to retrieve suspect product for investigation/evaluation have been made and documented.Complaint will be reopened if suspect product or investigation result arrives per (b)(4).

• Brand Name: CALIBRA CERAM MED REFILL
• Common Device Name: CEMENT, DENTAL
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20299901
• Report Number: 2515379-2024-00048
• Device Sequence Number: 12982544
• Product Code: EMA
• UDI-Device Identifier: D00261N0021
• UDI-Public: D00261N0021
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K073173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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 Catalogue Number: 607192K
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/24/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown