MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK KYPHX® HV-R? BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number CX01A

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problem Embolus (1830)

Event Date 01/29/2015

Event Type  Injury  

Event Description

It was reported that a patient underwent a balloon kyphoplasty at t5 and t6.The bone cement was stored at proper temperature and was mixed for 30 seconds.The cement was doughy and homogenous prior to delivery into the patient.Post-op, patient developed complication regarding chest pain associated with pmma extravasation into an anterior draining vein at t5.Patient underwent an open heart surgery to remove pmma embolus which required extended hospital stay.No further other information was reported.

Manufacturer Narrative

(b)(6).(b)(4).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.

• Brand Name: KYPHX® HV-R? BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4556011
• MDR Text Key: 5549570
• Report Number: 2953769-2015-00022
• Device Sequence Number: 1
• Product Code: NDN
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX01A
• Device Lot Number: WI14J041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2015
• 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
• Treatment: BKP KIT