MAUDE Adverse Event Report: SOADCO, S.L ESSENTIAL® CONE Ø4.0 X 12MM IMPLANT; DENTAL IMPLANT

Model Number	10 40 12
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Difficulty Chewing (4522)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The main cause of the loss may have been bone dis-integration due to mechanical overload because of poor osseous integration of the implant into the bone.This explains the initial stability of the implant at the time of implant connection but with subsequent marginal bone remodelling after loading the residual bone-implant contact has not been able to withstand the functional demand.
Event or Problem Description
The clinician reports that on the (b)(6) 2017 the implant was placed in position #2 and then on the (b)(6) 2018 he placed an abutment applying 30ncm torque and that it showed ideal clinical stability, absence of mobility, absence of radiolucid radriographic images and absence of symptomatology.Then, on the (b)(6) /2018 the prosthesis was placed.However, on the (b)(6) 2018 he had to extract the implant since the patient reports that at mastication he felt the crown lose and he tried to remove it by himself and pain started.The patient experienced pain and inflamation, at mastication, few days before the implant was removed.A normal surgical procedure was applied.

• Brand Name: ESSENTIAL® CONE Ø4.0 X 12MM IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): SOADCO, S.L; av. del pessebre, 76-82; escaldes- engordany., AD700 ; AN AD700
• Manufacturer (Section G): SOADCO, S.L; av. del pessebre, 76-82.; escaldes- engordany., AD700 ; AN AD700
• Manufacturer Contact: maria mitjaneta ; av. del pessebre, 76-82; escaldes- engordany., AD700 ; AN AD700
• MDR Report Key: 22284575
• Report Number: 3003267134-2025-00008
• Device Sequence Number: 8892830
• Product Code: DZE
• UDI-Device Identifier: 08435451602978
• UDI-Public: (01)08435451602978
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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 Expiration Date: 02/01/2020
• Device Model Number: 10 40 12
• Device Lot Number: 11976-991
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2015
• 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 Age: 72 YR
• Patient Sex: Male