MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHX® HV-R¿ BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number C01A-J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Pma 510(k).This part is not approved for use in the united states; however, the catalog # c01a and 510k # k041584 of 'like devices' was cleared in the united states.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.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on an unknown date (b)(6) 2015, patient underwent l2 balloon kyphoplasty.Post-op, on an unknown date, patient developed infection.Crp was 17 when the patient was hospitalized in the facility which was decreased to 4 at the time of the reporting.Abscess was found along left iliopsoas at levels l2-l3.On an unknown day in (b)(6) 2015, the patient consulted doctor in the hospital for back pain.On (b)(6) 2015, the patient underwent an anterior procedure in which bone cement was removed and iliac bone was grafted.Revision surgery will be scheduled on (b)(6) 2015 for posterior spinal fusion (th11, th12, l4, and l5).

• Brand Name: KYPHX® HV-R¿ BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5249500
• MDR Text Key: 32097738
• Report Number: 2953769-2015-00154
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: C01A-J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/25/2015
• 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
• Patient Outcome(s): Required Intervention