MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN; CEMENT, BONE, VERTEBROPLASTY

Model Number MSB_UNK_BKP_CEMENT

Device Problem Leak/Splash (1354)

Patient Problems Cyst(s) (1800); Dyspnea (1816); Extravasation (1842); Headache (1880); Hematoma (1884); Incontinence (1928); Muscle Weakness (1967); Paresis (1998); Ambulation Difficulties (2544); Peripheral Nervous Injury (4414); Unspecified Tissue Injury (4559)

Event Date 10/20/2022

Event Type  Injury  

Event Description

Summary: the article reviewed the case of a 65-year-old patient with unstable l1 fracture after trauma.The fracture was treated via balloon kyphoplasty, shortly after which the patient developed shortness of breath and severe headache.Subsequent computed tomography (ct) of the head revealed subarachnoid hemorrhage.Ct angiography did not reveal any intracranial aneurysms or arteriovenous malformations.A massive spinal subdural hematoma, which caused the patient to develop right leg paresis and hip joint weakness with grade 2¿3, was found during magnetic resonance imaging (mri).The hematoma was removed using multistage laminectomy th5-l3.A follow-up mri showed no pathological findings.Due to the unusual findings, spinal angiography was performed, revealing the artery of adamkiewicz (a.Radicularis magna, aka) on the l1 level on the right side.Control ct showed a suboptimal insertion of the needle into the right pedicle, which caused the injury of the artery.Reported events: 1.A 65-year-old patient was admitted to the department of neurosurgery after a fall.An l1 burst fracture was identified and treated with a balloon kp for severe therapy-resistant pain.The balloon kp was successful.Postoperative computed tomography (ct) revealed minimal cement leakage into the spinal canal.Shortly thereafter, the patient developed shortness of breath and severe headache.2.Subsequent brain ct revealed subarachnoid hemorrhage, primarily prepontine.As spinal pathology was suspected to be the cause of the bleeding, magnetic resonance imaging (mri) of the entire spine was performed.Spine mri revealed a massive ssh.After 2 days, he developed right leg paresis and hip joint weakness with grade 2¿3.It was decided that an immediate removal of the hematoma via multi-stage laminectomy on th5-l3 was necessary, and a lumbar drainage was placed.Subsequently, the paresis resolved, but fecal and urinary incontinence occurred.3.Another spine mri was performed, which did not reveal any pathological findings.As this was abnormal, spinal angiography was per formed, which demonstrated the aka (a.Radicularis magna) on the l1 level on the right side.A control ct revealed a suboptimal insertion of the needle into the right pedicle, which was responsible for the injury to the artery.4.The patient was followed up and after 1 year.The control spine mri showed multiple intraspinal cysts.The patient was incontinent and had hip flexor palsy and gait disturbance, and walking was only possible with a walker.See attached literature article.

Manufacturer Narrative

B3.Please note that this date is based off of the date of publication of article as the event dates were not provided in the published article.D4, g4.Product identifiers are unknown.H3.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.Slavkov dimitar "artery of adamkiewicz" korean j neurotrauma.2022 oct;18(2):399-403.Doi: 10.13004/kjnt.2022.18.E60.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 17085466
• MDR Text Key: 316941739
• Report Number: 1030489-2023-00406
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_BKP_CEMENT
• Device Catalogue Number: MSB_UNK_BKP_CEMENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2023
• 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: 65 YR
• Patient Sex: Male