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

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.

• Brand Name: KYPHX HV-R BONE CEMENT
• Type of Device: CEMENT, 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 Key: 12055979
• MDR Text Key: 258027614
• Report Number: 1030489-2021-00842
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• 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 Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Model Number: C01A
• Device Catalogue Number: C01A
• Device Lot Number: EL25508
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• 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
• Patient Age: 46 YR
• Patient Weight: 94