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

Model Number	MPI
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Circumstances are not clear due to lack of provided information.To date, no information has indicated that the device has contributed to the described event.If additional information will be received indicating otherwise, a follow-up report will be submitted.
Event or Problem Description
Failure to osseointegrate.

• 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: 19124408
• Report Number: 3010948854-2019-00002
• Device Sequence Number: 7760042
• Product Code: DZE
• UDI-Device Identifier: 07290109280363
• UDI-Public: 07290109280363
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140728
• 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
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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: 10/03/2023
• Device Model Number: MPI
• Device Catalogue Number: 13600
• Device Lot Number: MPI000179
• 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: 01/30/2019
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2018
• 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