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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Failure (2484)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

The following products were used in the surgery: product id: cx01b, qty: 02, lot# 0009428041, 510k: k163032, udi: (b)(4), product id: cx01a, qty: 02, lot# el70084, 510k: k163032, udi: (b)(4).Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.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 post-op on (b)(6) 2018, acute on-chronic respiratory failure and respiratory arrest led to patient's death.There was no relationship with the any of the products used/implanted in the surgery.

Manufacturer Narrative

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

Event Description

Procedure performed: l5 spine ablation.

Manufacturer Narrative

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

Event Description

Diagnostic test: ct with contrast diagnostic test date: (b)(6) 2018 diagnostic test result: no pulmonary embolism; increased disease; abnormal scan diagnostic test: x-ray diagnostic test date: (b)(6) 2018 diagnostic test result: r)lobe opacity/pleural effusion possible post obstructive infection.Abnormal date ae started: (b)(6) 2018.

Manufacturer Narrative

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

Event Description

Ae start date: (b)(6) 2018 ae diagnostic tests: diagnostic test: x-ray, diagnostic test result: no change from ct chest performed on (b)(6) 2018, diagnostic test date: (b)(6) 2018 diagnostic test: ct with contrast, diagnostic test result: increased post-obstructive consolidation of the right lung, diagnostic test date: (b)(6) 2018 ae sae: led to serious deterioration in the health of the patient that resulted in: in-patient or prolonged hospitalization.Site relatedness: study procedure related: probable identify the procedure: relationship to anesthesia sponsor relatedness: study procedure related: probable identify the procedure: relationship to anesthesia action taken/treatment: yes.

Manufacturer Narrative

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

Event Description

Date ae started: (b)(6) 2018 for the reported ae, the patient was given medication but no surgical procedure was performed.

• 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: 8188692
• MDR Text Key: 131128491
• Report Number: 1030489-2018-01691
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Device Manufactured: 11/08/2018
• 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): Hospitalization; Other
• Patient Age: 57 YR
• Patient Weight: 86