MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON EXPRESS; DISPENSER, CEMENT

Catalog Number F06B

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient was presented with 6 level painful vertebral compression fractures with levels implanted at t7-11.Intr a-op, the tip of the directional bone filler broke off when surgeon tried to remove it.It appeared to have snapped due to the torque from trying to twist it free.Product came in contact with the patient.No patient complications were reported.

Manufacturer Narrative

Additional information: device evaluation: the bone filler and tamp were returned with cement hardened inside.The back of the directional filler has been pulled out, from what appears to be excessive force.Per the reported event, the cement hardened faster than expected, causing the directional filler to become stuck.Since the cement was hardened when returned the setup time is unknown.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON EXPRESS
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7111868
• MDR Text Key: 94622724
• Report Number: 1030489-2017-02490
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2018
• Device Catalogue Number: F06B
• Device Lot Number: WI472178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 03/14/2018
• Supplement Dates FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2016
• 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
• Patient Age: 80 YR