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

Catalog Number	0607687000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: not available for return.
Event or Problem Description
It was reported by the physician to the sales rep that a few days after a kyphoplasty procedure was successfully completed that the patient returned complaining of shortness of breath.Upon imaging it was observed that cement had extravasated to the heart.Open heart surgery was performed to remove the cement.A majority of the cement was successfully removed except for one piece that was left behind.After further follow up, it was reported that the patient requested a second surgery to remove the piece of cement that was left behind and that during that second surgery, the piece of cement migrated to the lungs and was not removed.The patient was discharged from the hospital at that time.It was further reported that the patient returned to the hospital complaining of shortness of breath.At the time of this report, the patient was reported to be admitted at the hospital.Upon additional follow up with the rep, the rep was informed that the patient has a history of breast cancer.

• 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: 8619594
• Report Number: 0001811755-2019-01707
• Device Sequence Number: 2172954
• Product Code: LOD
• UDI-Device Identifier: 37613252039250
• UDI-Public: 37613252039250
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032945
• 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): 05/17/2019

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 05/17/2019
• 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: Required Intervention