MAUDE Adverse Event Report: ELMDOWN LIMITED KYPHX HV-R BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number C01A-J

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Type  Injury  

Manufacturer Narrative

This product is not approved for use in the us, however a like device with part# c01a, 510k# k041584 and upn (b)(4) is approved for the market.Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent balloon kyphoplasty (bkp) at th12 due to primary osteoporosis,compression fracture.After bkp operation was performed at th12, fusion was performed on the patient with screw at l1/2 and transverse hook at th12.After operation, the cement migrated to the ventral side.About half of the cement protruded.This was confirmed on (b)(6) 2018 in imaging.Reportedly, there was neurological symptom due to instability.There was no impact with blood vessel/macrovascular at present.Posterior fusion was planned to be performed later.

• Brand Name: KYPHX HV-R BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): ELMDOWN LIMITED; 38 wigmore st; london W1U 2 HA; GB W1U 2HA
• Manufacturer (Section G): ELMDOWN LIMITED; 38 wigmore st; london W1U 2 HA; GB W1U 2HA
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7446031
• MDR Text Key: 106004347
• Report Number: 1030489-2018-00575
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: C01A-J
• Device Lot Number: EL61316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2016
• 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