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

Catalog Number C01A-J

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

Pma 510(k): 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 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

It was reported that the patient underwent balloon kyphoplasty (bkp) at l2 due to primary osteoporosis, compression fracture.During the surgery, the cement hardened during injection with bone filler device (bfd) into the vertebral body and it could not be filled.The procedure was completed successfully with the original product.There was delay of less than 60 minutes in the overall procedure time.No patient complications were reported as a result of this event.

• 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: 7120259
• MDR Text Key: 95901899
• Report Number: 3008572623-2017-00001
• 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: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• 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: 11/15/2017
• 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 Age: 74 YR
• Patient Weight: 29