MAUDE Adverse Event Report: OSARTIS GMBH VERTECEM II CEMENT KIT

Model Number	08.702.016S
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	06/20/2020
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: VERTECEM II CEMENT KIT
• Manufacturer (Section D): OSARTIS GMBH; auf der beune 101; muenster, 64839 ; GM 64839
• MDR Report Key: 10412947
• Report Number: 9615014-2020-00009
• Device Sequence Number: 14123807
• Product Code: NDN
• UDI-Device Identifier: 04260056880759
• UDI-Public: 04260056880759
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

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 Model Number: 08.702.016S
• Device Catalogue Number: 08.702.016S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Weight: 60