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

Catalog Number C01A-J

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  Injury  

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.

Event Description

Patient demographics:(b)(6).Procedure: balloon kyphoplasty levels implanted: th12 surgery date: (b)(6) 2015 it was reported on 25 nov 2015 that post-op, the patient had been treated with teribone on an outpatient basis after discharge but pseudoarthrosis was found and also the patient complained of back pain.Revision surgery was operated with expedium (depuy's) to fix at 3a-2b on (b)(6) 2015.It was reported that the patient has pain in incision part after bkp was performed at t12, and the pain did not improve.The patient also has instability between cement and bone that explains pseudarthrosis.Revision surgery: the cement at th12 was removed and vertebral body was extracted, and t2 altitude (19ײ3) was placed.Pedicle screws were inserted at th9/10/11 and l1/2, and tlif was conducted at l1/2 and the surgery was completed.Doctor's comment: a patient with severe osteoporosis becomes like this.After the bkp, the patient is being given teriparatide acetate as described before.The post-op status of the patient (outcome of pain) is good.The patient reports no pain.

• 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: 5326430
• MDR Text Key: 34324194
• Report Number: 1030489-2015-03575
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: C01A-J
• Device Lot Number: EL50614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00081 YR
• Patient Weight: 75