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

Catalog Number C01A

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

Patient Problem Pain (1994)

Event Date 06/04/2012

Event Type  Injury  

Manufacturer Narrative

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 medtronic devices contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that the patient underwent balloon kyphoplasty on (b)(6) 2011 for compression fracture at l1 due to osteoporosis.Post-operatively on (b)(6) 2012 during long-term follow-up, worsening of back pain was noted.The low back pain was the main complaint of the patient and it was considered that it is worsening.The surgeon commented that he determined that it was improved on (b)(6) 2012.It was considered that the event was due to the patient-specific factor and was not casually related to the balloon kyphoplasty.The product came in contact with the patient.No delay in procedure was reported.No product malfunction was associated with the cement.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5895887
• MDR Text Key: 52725634
• Report Number: 2953769-2016-00061
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041584
• 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,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: C01A
• Device Lot Number: EL35410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• 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
• Patient Age: 82 YR
• Patient Weight: 45