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 Extravasation (1842); Paraplegia (2448)

Event Date 07/04/2023

Event Type  Injury  

Manufacturer Narrative

A2: age - average age of 15 patients was 73.7 years (range from 62 to 82) a3: sex - 9 male and 9 female (total 15 patients) g2: the country of the event is south korea h6: the device is not accessible/returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Citation: chi ho kim, pius kim, chang il ju and seok won kim.Open surgery for osteoporotic compression fracture within one month of single level balloon kyphoplasty.Korean neurotraumatology society.2023 sep;19(3):348-355.Doi.Org/10.13004/kjnt.2023.19.E33.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.

Event Description

Citation: chi ho kim, pius kim, chang il ju and seok won kim.Open surgery for osteoporotic compression fracture within one month of single level balloon kyphoplasty.Korean neurotraumatology society.2023 sep;19(3):348-355.Doi.Org/10.13004/kjnt.2023.19.E33.Event summary: this study aimed to analyze the reasons for open surgery performed within one month of balloon kyphoplasty (bkp) for osteoporotic compression fractures. this study included 15 patients (male:female=6:9) who underwent open surgery within one month after bkp in our institute from 2013 to 2020.Among them, 10 patients underwent bkp in our institution and 5 patients were transferred because of adverse events after undergoing bkp at another hospital. all patients were followed up for at least 12 months after surgery (average time 15.5 months, range 12¿39 months). the mean age of the patients was 73.7 years with a range from 62 to 82. clinical findings including main indications, neurological deficits, and clinical course were analyzed.Reported events: open surgery was performed for neurological deficits or uncontrolled back pain after bkp within one month due to cement dislodgement, cement leakage into the spinal canal, improper needle insertion, spinal epidural fluid and acute spinal subdural hematoma (sdh). the main reasons for open surgery were cement mass dislodgement and neural injury caused by puncture errors or cement leakage into the spinal canal.1.7 patients had back pain due to dislodgement of the cement mass or spinal instability. transpedicular screw fixation with bone grafting after decortication of the posterolateral fusion bed, a mixture of local bone chips was performed (posterior fusion) in 7 patients for cement dislodgement. all 7 patients with cement dislodgement had the presence of an intravertebral cleft (ivc) or increased angular motion on dynamic radiographs.Complete relief of back pain was achieved after surgery in all 7 patients with cement dislodgement.2.3 patients had neural injury (paraparesis and radiating pain) due to cement leakage to nerve root canal in 2 patients and cement leakage to thoracic vertebral canal in 1 patient.The patients showed significant spinal cord compression or nerve root canal stenosis caused by cement leaks and neural damage was mainly caused by mechanical compression, not the burning of cement extravasation. posterior lumbar interbody fusion (plif) following removal of leaked cement or decompressive laminectomy without instrumentation was performed and patients obtained good neurological function recovery.3.3 patients had spinal cord injury (paraparesis) caused by a malposition of the puncture needle due to the difficulties in the ins ertion of large gauge trocars into a vertebral body through pedicles and the spinal cord was directly damaged.Posterior lumbar interbody fusion (plif) following decompressive laminectomy without instrumentation was performed.4. two patients developed acute spinal subdural hematoma, and spinal epidural fluid was pushed out at the back edge of the vertebral body following bkp. one patient who had ivc showed acute paraparesis caused by the spinal epidural fluid at the back edge of the vertebra without cement dislodgement or cement leakage underwent bone cement augmented percutaneous screw fixation and showed complete recovery of paraparesis.One patient developed an acute spinal sdh without signs of cement leakage to the spinal canal.Due to the acute motor deficit in the lower limbs, emergent decompressive laminectomy at the level of bkp was performed.Six out of 8 patients who had sci or nri due to cement leakage, acute spinal sdh, spinal epidural fluid or puncture mistake during bkp showed recovery of sci or nri in terms of asia-evaluated level.However, the other 2 patients with sci directly damaged by a puncture mistake remained at the same asia-evaluated level.

Manufacturer Narrative

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: 18299565
• MDR Text Key: 330112919
• Report Number: 1030489-2023-00840
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• 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: 12/18/2023
• 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): Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female