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 Inadequate Pain Relief (2388)

Event Date 03/22/2017

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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Pre-operative diagnosis: primary osteoporosis (type of fracture -compression fracture) level: t12 it was reported that the patient was enrolled in for study.The patient was hospitalized on (b)(6) 2011 and discharged on (b)(6) 2011.It was reported that on unknown date, post-op, patient complained of back pain.Patient back pain did not resolve completely even 12 months after the surgery.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

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 2000 ; CH 2000
• Manufacturer (Section G): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; CH 2000
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6496708
• MDR Text Key: 72876564
• Report Number: 2953769-2017-00036
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 00613994583215
• UDI-Public: 00613994583215
• 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,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: C01A
• Device Lot Number: EL34910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• 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: 69 YR
• Patient Weight: 55