MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON XPEDE BONE CEMENT AND KYPHON MIXER PACK; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	CX01B
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Dyspnea (1816)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
Event or Problem Description
It was reported that on an unknown date, patient underwent balloon kyphoplasty at t11-l2 for vertebral compression fracture.Post-op, bone cement had leaked into the pulmonary system.Patient was initially asymptomatic but started complaining of shortness of breathe on (b)(6) 2016.Patient underwent exams which showed a 7 cm piece of cement lodged in her vein.When the treating physician had attempted to remove the cement on (b)(6) 2016, the cement broke into smaller pieces and traveled to her lungs.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON XPEDE BONE CEMENT AND KYPHON MIXER PACK
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis,tn
• MDR Report Key: 6244737
• Report Number: 1030489-2017-00082
• Device Sequence Number: 18938960
• Product Code: NDN
• UDI-Device Identifier: 00613994831507
• UDI-Public: 00613994831507
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2016

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: CX01B
• Device Lot Number: EL58216
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: 12/14/2016
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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; Required Intervention
• Patient Age: 64 YR