MAUDE Adverse Event Report: J DENTAL CARE S.R.L. JDEVOLUTION PLUS; JDEVOLUTION PLUS DENTAL IMPLANT

Catalog Number	EV37115:
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dhr for lot 01-04-23-8024 was reviewed, and no evidence of defects or non-conformities was identified for the product under complaint.The results of the investigation confirm that both the manufacturing and sterilization processes are in compliance.Quality control procedures ensure that batches meet the necessary specifications before distribution.
Event or Problem Description
Implant ev37115: was inserted in position 35 on (b)(6)2025.The patient (female sex, age 77) had no special clinical conditions.Insertion was performed with contra-angle using an end torque of 35 ncm.During the submerged healing period, there was failure to osseointegrate the implant, which was therefore subsequently removed.At the time of removal, the patient felt pain.

• Brand Name: JDEVOLUTION PLUS
• Common Device Name: JDEVOLUTION PLUS DENTAL IMPLANT
• Manufacturer (Section D): J DENTAL CARE S.R.L.; via dino campana 2; modena, 41123 ; IT 41123
• MDR Report Key: 21363187
• Report Number: 3013264549-2025-00001
• Device Sequence Number: 12871283
• Product Code: DZE
• UDI-Device Identifier: 08055510170080
• UDI-Public: 08055510170080
• Combination Product (Y/N): N
• PMA/510(K) Number: K143142
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2025

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
• Device Catalogue Number: EV37115:
• Device Lot Number: 01-04-23-8024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female