MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH HEALDESIGN EV 4.2 Ø5-6.5MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	25797
Medical Device Problem Codes	Fracture (1260); Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the initial reporter and our experience in the investigation of similar complaints.Product return is requested and product will be evaluated after receipt.In case any new or additional information will be gained from this investigation a follow-up report will be sent.Trend is tracked and monitored.
Event or Problem Description
It was reported that a patient experienced a fracture of a dental screw.
Additional Manufacturer Narrative
Additional information received: healing abutment could not be removed which led to the explanation of the implant.This is a follow up report for this additional information.Additional fda coding being added after investigation of device.Adding additional type of investigation code 10.This is a follow up report to add this additional code.1924//4627//2547/-//4112,10//3253//22.This is to correct and remove the codes that were initially reported - removing codes.For: medical device problem code - 1260.Investigation findings code - 3252.The correct codes for this complaint are: medical device problem code - 2547.Investigation findings code - 3253.This is a follow up report to correct these/this code(s).Correcting section b5 describe event or problem from: it was reported that a patient experienced a fracture of a dental screw.To: dentsply sirona became aware of a malfunction that occurred while using the astra tech implant system ev.This report is for the dental abutment device.The dental implant device report was submitted under mfr report #.Trend is tracked and monitored.
Event or Problem Description
Dentsply sirona became aware of a malfunction that occurred while using the astra tech implant system ev.This report is for the dental abutment device.The dental implant device report was submitted under mfr report #.Trend is tracked and monitored.

• Brand Name: HEALDESIGN EV 4.2 Ø5-6.5MM
• 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: 24111585
• Report Number: 3013111692-2026-02832
• Device Sequence Number: 20191195
• Product Code: DZE
• UDI-Device Identifier: 07392532153662
• UDI-Public: 07392532153662
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 25797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/29/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown