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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK USA, INC KYPHON XPEDE BONE CEMENT CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Model Number CX01B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 08/17/2021
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
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for l3 vertebral compression fracture. It was reported that case done successfully on (b)(6) 2021. Patient developed an infection at the treated level.  patient was placed on intravenous antibiotics. There were no further complications reported regarding the event. Additional information received on 27-aug-2021: the infection was not resolved. No additional surgical intervention needed. Unable to be determined if mdt product were responsible for infection.
 
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Brand NameKYPHON XPEDE BONE CEMENT
Type of DeviceCEMENT, 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
david gustafson
1800 pyramid place
memphis, TN 38132
7635149628
MDR Report Key12444966
MDR Text Key270537659
Report Number1030489-2021-01134
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102397
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCX01B
Device Catalogue NumberCX01B
Device Lot Number0010664564
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 Received08/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/03/2021
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: 09/09/2021 Patient Sequence Number: 1
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