MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) HEALDESIGN EV (L) Ø6.5 4.5MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	68013029
Medical Device Problem Codes	Failure to Osseointegrate (1863); Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative
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.Additional fda coding being added after investigation of device.Adding additional investigation conclusions 61.This is a follow up report to add this additional code.Device received for this event is being corrected from primetaper ev ø4.8 x 11mm os catalog # 68011106 udi # (b)(4) lot number 513093.To healdesign ev (l) ø6.5 4.5mm catalog # 68013029 udi # (b)(4) lot number unk.This is a follow up report for this corrected information.Correcting concomitant medical products from ha 68013029 to primetaper ev ø4.8 x 11mm os, ref (b)(4), lot 513093.This is a follow up report for this corrected information.This is to correct and remove the codes that were initially reported - removing codes for: medical device problem code: remove 1863.Investigation findings: remove 3221.The correct codes for this complaint are: medical device problem code: add 2547.Investigation findings: add 3253 and 4248.This is a follow up report to correct this code.

• Brand Name: HEALDESIGN EV (L) Ø6.5 4.5MM
• 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: 21526098
• Report Number: 9612468-2025-00299
• Device Sequence Number: 8455596
• Product Code: DZE
• UDI-Device Identifier: 07392532259715
• UDI-Public: 07392532259715
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 68013029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/06/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HA 68013029; PRIMETAPER EV Ø4.8 X 11MM OS, REF 68011106, LOT 51
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown