MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AUTOPLEX SYSTEM: W/ VERTAPLEX HV; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT

Catalog Number	0607687000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	03/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not available.
Event or Problem Description
It was reported that a patient who had received a vertebralplasty procedure had returned to the hospital complaining of shortness of breath.After a ct scan was performed, cement was located in the patient's lungs and heart.Attempts are being made to obtain additional information from the user facility.
Additional Manufacturer Narrative
This correction is being filed to update outcomes attributed to the adverse event.
Event or Problem Description
It was reported that a patient who had received a vertebralplasty procedure had returned to the hospital complaining of shortness of breath.After a ct scan was performed, cement was located in the patient's lungs and heart.Attempts are being made to obtain additional information from the user facility.

• Brand Name: AUTOPLEX SYSTEM: W/ VERTAPLEX HV
• Common Device Name: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8578444
• Report Number: 0001811755-2019-01588
• Device Sequence Number: 2191593
• Product Code: LOD
• UDI-Device Identifier: 37613252039250
• UDI-Public: 37613252039250
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K032945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0607687000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 11/28/2020
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 11/30/2020
• 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