MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHOPLASTY; ARTHROSCOPE

Device Problem Unstable (1667)

Patient Problems Infiltration into Tissue (1931); Pain (1994)

Event Type  Injury  

Event Description

Presentation of 3 cases of treatment of an iatrogenic spondylitis after a kyphoplasty and a review of literature.A retrospective study of analysis on 3 cases from january 2003 to march 2013 with spondylitis with a kyphoplasty being done previously.Case 1: (b)(6) year old patient therapied in a different hospital with a kyphoplasty due to vertebral compression fracture at t12.One week post-op, increased pain and transferred to a new hospital.Mri showed liquid in the placed cement and stenosis of spinal canal and an edema at upper plate of l1.Spondylitis was seen at t12/l1.Patient underwent therapy of dorso-ventral spondylodesis at t11/12 ¿ l1/2 with replacement of vertebral body.Case 2: (b)(6) old patient therapied in a different hospital with a kyphoplasty due to vertebral compression fracture at t8.4 weeks later, patient was transferred to a different hospital with mri and ct showing spondylitis t6-t10.Patient suffered ¿violent¿ pain caused by instability.X-ray showed instability with infiltration of the paravertebral tissue.Patient underwent therapy of dorso-ventral spondylodesis at t6/7 ¿ t9/10 with replacement of vertebral body.Case 3: (b)(6) old patient with kyphoplasty (lumbar vertebral bodies 1, 4, and 5).Two months post-op, patient transferred to different hospital due to violent pain.Mri showed liquid paravertebral in the right 1st vertebral body and between upper plate at 1st lumbar vertebral body.Therapied with a dorso-ventral spondylodesis at t10 ¿ l3 with replacement of 1st lumbar vertebral body.All patients are free from pain and complications till now.

Manufacturer Narrative

(b)(4).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: KYPHOPLASTY
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ch 2000 ; CH 2000
• 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: 3657960
• MDR Text Key: 4280285
• Report Number: 2953769-2014-00027
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2014
• 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