MAUDE Adverse Event Report: STRATASYS LTD. TRUEDENT

Catalog Number	OBJ-09169
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In addition to the mentioned before defective catridge, the catridge with udi number (b)(4), batch number 23123-09166 and part number obj-09166 had the same problem as the catridge with the batch number 22861-09169.
Event or Problem Description
The cartridge is not recognised by the printer (rfid).

• Brand Name: TRUEDENT
• Common Device Name: TRUEDENT
• Manufacturer (Section D): STRATASYS LTD.; 10 habarzel st.; kiryat gat, 82583 10; IS 8258310
• Manufacturer (Section G): STRATASYS LTD.; 10 habarzel st.; kiryat gat, 82583 10; IS 8258310
• Manufacturer Contact: inna barsky ; 1 holtzman st.; rehovot, 76124-01 ; IS 7612401
• MDR Report Key: 21620853
• Report Number: 3016074824-2025-00018
• Device Sequence Number: 6837806
• Product Code: EBI
• UDI-Device Identifier: 07290018915806
• UDI-Public: 07290018915806
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment,Relabeling
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2024
• Device Catalogue Number: OBJ-09169
• Device Lot Number: 22861-09169
• 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: 01/08/2024
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown