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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 Bone Fracture(s) (1870); Unspecified Infection (1930)
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 in a literature article titled¿ delayed height loss after kyphoplasty in osteoporotic vertebral fracture with severe collapse: comparison with vertebroplasty¿ that a total of 46 patients underwent kyphoplasty and vertebroplasty surgery. Post-op complications included patient having a spinal infection after vp. New adjacent segment fractures were identified in 10 patients from both the groups. All occurring within 3 months. All patients underwent conservative treatments, including pain medications and braces, for new fractures.
 
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Brand NameCEMENT, BONE, VERTEBROPLASTY
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 Key8150866
MDR Text Key129913491
Report Number1030489-2018-01634
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 12/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2018
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

Patient Treatment Data
Date Received: 12/11/2018 Patient Sequence Number: 1
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