MAUDE Adverse Event Report: OSARTIS GMBH VERTECEM II CEMENT KIT

Model Number 08.702.016S

Device Problems Use of Incorrect Control/Treatment Settings (1126); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 06/20/2020

Event Type  Injury  

Event Description

It was reported that, the vertecem ii cement was noticed to have extruded into the patient's vena cava.Initially, the patient underwent an l4 corpectomy with screws and vertecem cement at l3-5 on (b)(6) 2020.It is unknown how the issue was discovered.It is unknown if there was a patient consequence.Concomitant device reported: unknown screw (lot # unknown).This complaint involves one (1) device.

• Brand Name: VERTECEM II CEMENT KIT
• Type of Device: VERTECEM II CEMENT KIT
• Manufacturer (Section D): OSARTIS GMBH; auf der beune 101; muenster, 64839 ; GM 64839
• Manufacturer (Section G): OSARTIS GMBH; auf der beune 101; muenster, 64839 ; GM 64839
• Manufacturer Contact: volker stirnal ; auf der beune 101; muenster, 64839 ; GM 64839
• MDR Report Key: 10412947
• MDR Text Key: 203105484
• Report Number: 9615014-2020-00009
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 04260056880759
• UDI-Public: 04260056880759
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 08.702.016S
• Device Catalogue Number: 08.702.016S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 60