MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON XPEDE BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number CX01A

Device Problem Migration (4003)

Patient Problems Extravasation (1842); Low Blood Pressure/ Hypotension (1914); Weakness (2145)

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with sacral fracture and pain; and underwent l2-illum fusion with fenestrated screws.On or around (b)(6) 2019, post-op, cement leakage into the vascular system was observed.On (b)(6) , the patient presented to the emergency room with weakness and hypotension.Hence, 2 subsequent surgeries were performed on (b)(6) 2019 to remove cement shard from right ventricle and to remove cement from right pulmonary artery.Patient's condition after the revision surgery is unknown.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported via medwatch (mw5088978) that the patient emergently returned to hospital.Exploratory laparotomy and exploration of vena cava found 4-5 cm white hard foreign body.Patient was taken to operating room for median sternotomy exploration of right ventricle and right pulmonary artery finding a 4-5 cm white hard foreign body.

• Brand Name: KYPHON XPEDE BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• 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: 8964849
• MDR Text Key: 156594008
• Report Number: 1030489-2019-00983
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 00643169097797
• UDI-Public: 00643169097797
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163032
• 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: 10/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX01A
• Device Lot Number: EL70018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2019
• 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): Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 63