MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) PRIMETAPER EV Ø5.4 X 9MM OS; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	68011112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Insufficient Information (4580)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While it is unknown if the device used in this case caused or contributed to the patient¿s symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.A patient reported having an allergy and needs to be tested.No further information could be obtained.Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.
Event or Problem Description
In this event it is reported the patient alleged to have an allergic reaction to primetaper ev ø5.4 x 9mm os.Several requests were made to get additional information.Symptoms are unknown and whether the implants were removed or a removal is planned.

• Brand Name: PRIMETAPER EV Ø5.4 X 9MM OS
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal vastra gotalands lan [ S-431 21; SW S-431 21
• Manufacturer (Section G): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal vastra gotalands lan [ S-431 21; SW S-431 21
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20543521
• Report Number: 9612468-2024-01520
• Device Sequence Number: 7481181
• Product Code: DZE
• UDI-Device Identifier: 07392532258824
• UDI-Public: 07392532258824
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/28/2024

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: 68011112
• Device Lot Number: 516777
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/01/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown