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

Model Number	ULT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Circumstances are not clear due to the lack of provided information, for infection event a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions / patient habits (e.G.Oral hygiene, etc.).In addition, no signals were found indicating potential non-conformances affecting the manufacturing and sterilization processes, therefore it has been assessed and concluded to be unlikely related in high level of confidence.If additional information is received indicating otherwise, a follow-up report will be submitted.
Event or Problem Description
Infection.

• 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: 20379671
• Report Number: 3010948854-2022-00053
• Device Sequence Number: 9592437
• Product Code: DZE
• UDI-Device Identifier: 07290109280721
• UDI-Public: 07290109280721
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K161497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2024

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: 01/27/2024
• Device Model Number: ULT
• Device Catalogue Number: 16420
• Device Lot Number: ULT000049
• 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: 02/15/2022
• Initial Report FDA Received Date: 10/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2019
• 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: 83 YR
• Patient Sex: Male