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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY

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MEDTRONIC SOFAMOR DANEK USA, INC KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Model Number C01A
Device Problem Migration (4003)
Patient Problems Aspiration/Inhalation (1725); Extravasation (1842); Hypoxia (1918); Muscle Weakness (1967); Pain (1994); Stenosis (2263)
Event Date 10/01/2009
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. Other: anoxia. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the consumer via the manufacturer representative regarding an event which occurred post a l2-l3 lumbar kyphoplasty procedure. It was reported that the bone cement departed the vertebral bodies, hardening in the outside spaces. The patient had lower back pain. The patient continued his physical therapy. Mri done on (b)(6) 2016 showed disc protrusion from l1 to s1. Ncv done (b)(6) 2020, confirmed lumbar radiculopathy. Patient medication: hydrocodon, topomax, cbd oil and medical marijuana. Patient history: status post crush injury l2, l3 and l5 with failed surgical repair. Lumbar radiculopathy procedure details: patient underwent kyphoplasty of the lumbar spine at l2 and l3. Then a further kyphoplasty for l5 during which l4 was mistakenly addressed. Patient outcome: patient aspirated causing anoxia for several minutes, debilitating pain, right lower extremity weakness, absence of reflexes in the right leg, disc protrusion, stenosis.
 
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Brand NameKYPHX HV-R 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
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key12055979
MDR Text Key258027614
Report Number1030489-2021-00842
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2011
Device Model NumberC01A
Device Catalogue NumberC01A
Device Lot NumberEL25508
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/24/2021 Patient Sequence Number: 1
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