MAUDE Adverse Event Report: KYPHON NEUCHATEL KYPHOPLASTY; ARTHROSCOPE

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

Patient Problem Unspecified Infection (1930)

Event Date 05/28/2013

Event Type  Injury  

Event Description

It was reported via a literature article entitled "infection after vertebroplasty or kyphoplasty.A series of nine cases and review of literature." that a case series with a long-term follow-up of spinal infection after vertebroplasty/kyphoplasty was reviewed.A retrospective, uncontrolled clinical case series in a single institution.Between january 1997 and june 2012, 1307 patients underwent percutaneous vertebroplasty or kyphoplasty.Six cases had post-operative infection and three additional cases were referred from other institutions for salvage treatment.Nine patients were included: six females and three males (mean age was 73.8 years).Co morbidities were found in all patients.Kyphoplasty was done in five patients and vertebroplasty was done in 4.Three cases with early infection presented within 1 month.Infection parameters were high in all patients at re-admission.All patients were treated surgically except one case who died before the planned revision surgery.In all cases, debridement and corpectomy were done through anterior approaches combined with posterior instrumentation.Most common causative organism was (b)(6) in three cases.Mean follow-up period after revision was 26.68 months, excluding two patients who died early in the follow-up period (within 9 months).At the end of the follow-up, two patients had unrestricted activities and one patient required a walker.Of three par-paretic patients, two improved functionally and could walk unassisted and one improved but still used a wheelchair.

Manufacturer Narrative

(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: KYPHOPLASTY
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): KYPHON NEUCHATEL; kyphon sarl; pierre-a-bot 97; neuchatel,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: 3602452
• MDR Text Key: 4190247
• Report Number: 2953769-2014-00015
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/10/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2014
• Initial Date FDA Received: 01/31/2014
• 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): Required Intervention; Disability