MAUDE Adverse Event Report: DITRON DENTAL LTD ULTIMATE PRECISION IMPLANT; DENTAL IMPLANT

Model Number	ULT
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.
Additional Manufacturer Narrative
Circumstances are not clear due to the lack of provided information.To date, no information has indicated that the device or the way it was used has contributed to the described event.In addition, no signals were found indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to osseointegration problem, and escaping the available detections has been assessed and concluded to be unlikely in high level of confidence.If additional information is received indicating otherwise, a follow-up report will be submitted.

• Brand Name: ULTIMATE PRECISION IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): DITRON DENTAL LTD; 2 haofe st.; southern industrial zone; ashkelon, israel 78780 02; IS 7878002
• Manufacturer (Section G): DITRON DENTAL LTD; 2 haofe st.; southern industrial zone; ashkelon, israel 78780 02; IS 7878002
• Manufacturer Contact: 2 haofe st.; southern industrial zone; ashkelon, israel 78780-02
• MDR Report Key: 21271400
• Report Number: 3010948854-2024-00161
• Device Sequence Number: 8080250
• Product Code: DZE
• UDI-Device Identifier: 07290109280714
• UDI-Public: 07290109280714
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K161497
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

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 Model Number: ULT
• Device Catalogue Number: 16375
• Device Lot Number: ULT000530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2024
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2023
• 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