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

Catalog Number CX01B

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Dyspnea (1816)

Event Type  Injury  

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 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.

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
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis,tn
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis,tn
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6244737
• MDR Text Key: 64577180
• Report Number: 1030489-2017-00082
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 00613994831507
• UDI-Public: 00613994831507
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: CX01B
• Device Lot Number: EL58216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: 12/14/2016
• Supplement Dates FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR