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
Event or Problem Description
The cartridge is not recognised by the printer (rfid).
Additional Manufacturer Narrative
In addition to the mentioned before cartridge number obj-09169 and exp date 01022024, the same problem of the "cartridge dates are reading wrong" happened with obj-09166 (batch number 23123-09166, udi (b)(4) and exp date 01052024) and obj-09169 (batch number 22861-09169, udi: (b)(4), exp date 03012024).

• 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: 21630115
• Report Number: 3016074824-2025-00019
• Device Sequence Number: 8479604
• Product Code: EBI
• UDI-Device Identifier: 07290018915806
• UDI-Public: 07290018915806
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/18/2025

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: 03/18/2025
• 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