MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; CEMENT, BONE, VERTEBROPLASTY

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

Patient Problems Embolism (1829); Bone Fracture(s) (1870); Hematoma (1884); Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Although it is unknown if the device caused or contributed to the reported event or not, we are filing this report for notification purposes.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

The event details listed were obtained on (b)(6) 2018 per the cer "(b)(4)- cer for vertebroplasty and balloon kyphoplasty devices" conducted from a data set from 2007 to 2016 which contained a multi literature article review, which could contain duplicated information obtained from other literature articles reported to verify clinical safety and performance of the vertebroplasty and balloon kyphoplasty devices.Adverse events/complications attributed to devices: fractures/4 musculoskeletal disorders/4 infections /2 back pain/2 hematoma/2 injury and procedural complications/1 cement embolism/1.

• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7377901
• MDR Text Key: 103717919
• Report Number: 1030489-2018-00472
• 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,literatur
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• 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?: No
• Date Manufacturer Received: 02/27/2018
• 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): Other