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

Catalog Number C01A-J

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Stenosis (2263); No Code Available (3191)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent balloon kyphoplasty procedure (bkp) at l3 to treat vertebral compression fracture.The patient's anterior longitudinal ligament was "connected" at levels th11-l2 due to diffused idiopathic skeletal hyperostosis (dish).Post-op, it was reported that on (b)(6) 2015, the patient developed lower extremity pain due to vertebral collapse of l3 and stenosis led by cement migration in the vertebrae.On (b)(6) 2015, patient underwent revision surgery to perform decompression at l3 and posterior fixation at levels 3-above 2-below.Patient's post-revision course was well.Surgeon commented that cranial levels that suffered dish might have pulled cranial endplate of l3 and fracture at the endplate was occurred that resulted the cement migration.He also commented that bkp for the patient who had dish was "difficult" but thought the revision recovered the situation.

• 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: 5179338
• MDR Text Key: 29292333
• Report Number: 2953769-2015-00144
• 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
• Report Date: 09/29/2015

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?: Yes
• 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: Not provided
• Initial Date FDA Received: 10/27/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00085 YR
• Patient Weight: 41