MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK KYPHON HV-R BONE CEMENT AND KYPHON MIXER PACK; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	C01B
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.(b)(4).X-ray image review: post-op x-ray for t12 kyphoplasty shows peri-spinal venous cement extravasation in ap view.No lateral films provided.This is a known risk of kyphoplasty.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 or Problem Description
It was reported that on (b)(6) 2016, patient underwent balloon kyphoplasty for vertebral compression fracture.Intra-op, cement extravasation was observed.There was no delay in the overall procedure time.Patient was symptomatic and was detected with right sided flank pain post-operatively.Surgeon did not believe the symptoms that patient is having is related to event.According to the surgeon, patient is hypochondriac and the flank pain had nothing to do with the cement extravasation.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON HV-R BONE CEMENT AND KYPHON MIXER PACK
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 6177781
• Report Number: 1030489-2016-03429
• Device Sequence Number: 16400305
• Product Code: NDN
• UDI-Device Identifier: 00613994515155
• UDI-Public: 00613994515155
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C01B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2016
• Supplement Date Received by Manufacturer: 11/18/2016
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1