MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AUTOPLEX SYSTEM: W/ VERTAPLEX; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number	0605687000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Discarded.
Event or Problem Description
It was reported by the physician that there was dissatisfaction with the visualization of the cement during the procedure.It was further reported that the cement leaked into the anterior portion of the vertebral body.There were no adverse consequences to the patient and the procedure was completed successfully.

• Brand Name: AUTOPLEX SYSTEM: W/ VERTAPLEX
• Common Device Name: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8261210
• Report Number: 0001811755-2019-00158
• Device Sequence Number: 10805065
• Product Code: JDZ
• UDI-Device Identifier: 37613154687160
• UDI-Public: 37613154687160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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 Catalogue Number: 0605687000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1