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

Model Number	MPI
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: MOLECULAR 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: 20804102
• Report Number: 3010948854-2022-00273
• Device Sequence Number: 9849264
• Product Code: DZE
• UDI-Device Identifier: 07290109280257
• UDI-Public: 07290109280257
• 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): 11/28/2024

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 Model Number: MPI
• Device Catalogue Number: 11330
• 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: Not provided
• Initial Report FDA Received Date: 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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