MAUDE Adverse Event Report: OSARTIS GMBH VERTECEM II MIXING KIT

Model Number	08.702.017S
Medical Device Problem Codes	Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, a vertecem ii mixing kit and vertecem v+ syringe kit for a kyphoplsty case did not have intact sterile seals so the physician did not want to use them and would like replacements.Back up stock was available and he used those.No effect on patient was reported.

• Brand Name: VERTECEM II MIXING KIT
• Common Device Name: VERTECEM II MIXING KIT
• Manufacturer (Section D): OSARTIS GMBH; auf der beune 101; muenster, hesse 64839 ; GM 64839
• Manufacturer (Section G): OSARTIS GMBH; auf der beune 101; muenster, hesse 64839 ; GM 64839
• Manufacturer Contact: volker stirnal ; auf der beune 101; muenster, hesse 64839 ; GM 64839
• MDR Report Key: 17360025
• Report Number: 9615014-2023-00011
• Device Sequence Number: 6488541
• Product Code: LOD
• UDI-Device Identifier: 04260056880759
• UDI-Public: 04260056880759
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K121876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 07/20/2023

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: 11/30/2023
• Device Model Number: 08.702.017S
• Device Catalogue Number: 08.702.017S
• Device Lot Number: 2E60170
• 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: 06/21/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VERTECEM V+ SYRINGE KITREF03.702.215SLOT2012587
• Patient Sex: Unknown