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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK CEMENT, BONE, VERTEBROPLASTY Back to Search Results
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.
 
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Type of DeviceCEMENT, 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 Key7377901
MDR Text Key103717919
Report Number1030489-2018-00472
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received03/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2018
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 Treatment Data
Date Received: 03/28/2018 Patient Sequence Number: 1
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