MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH HEALDESIGN EV (L) Ø6.5 4.5MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	68013029
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
Event or Problem Description
In this event it is reported the patient alleged to have an allergic reaction to healdesign ev (l) ø6.5 4.5mm.Several requests were made to get additional information.Symptoms are unknown and whether the implants were removed or a removal is planned.
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.

• Brand Name: HEALDESIGN EV (L) Ø6.5 4.5MM
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20543531
• Report Number: 3013111692-2024-32550
• Device Sequence Number: 20703418
• Product Code: DZE
• UDI-Device Identifier: 07392532277672
• UDI-Public: 07392532277672
• 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: 68013029
• Device Lot Number: 517472
• 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