MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. MTS SPINAL SURGERY TOP; SURGICAL OPERATING TABLE

Model Number 5943

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Stenosis (2263); Spinal Cord Injury (2432)

Event Type  Injury  

Event Description

From "ammar a, zarnegar r, yassari r, kinon m.Large central lumbar disc herniation causing acute cauda equina syndrome with loss of evoked potentials during prone positioning for surgery.Surg neurol int.2018 mar 19;9:66.Doi:10.4103/sni.Sni_482_17.Ecollection 2018.Pubmed pmid: 29629233; pubmed central pmcid: pmc5875114." a (b)(6) obese male presented with 7 days of low back pain radiating down both lower extremities accompanied by a mild 4/5 right foot drop.The lumbar mri demonstrated a large l2-3 central disc herniation/stenosis resulting in marked thecal sac/nerve root compression.When placed prone on a jackson table, the preoperative sep/mep baselines were completely lost.Potentials immediately returned when he was returned to the supine position.When repositioned prone, although signals were again lost, the surgeons proceeded with an emergent l2-l3 laminectomy/discectomy; by the end of the procedure, the signals returned to the baseline bilaterally.Postoperatively, the patient fully recovered.Intraoperative neurophysiologic monitoring is useful in predicting neurologic compromise in patients with significant compressive spinal pathologies.Here, it was useful in a patient exhibiting a massive l2-3 disc herniation with stenosis resulting in cauda equina syndrome.Although sep/meps were lost both times the patient was placed prone on the jackson table prior to surgery, the second time it was elected to proceed with an immediate decompression.Potentials likely dropped due to prone positioning on the jackson table - the position probably acutely increased the lumbar lordosis, exacerbated the stenosis, and increased the epidural pressure.In the future, one should consider placing such patients on a wilson frame that offers a less lordotic posture.In these situations, neurophysiologic monitoring (sep/mep) can alert the surgeon of impending neurological injury warranting urgent decompression.

Manufacturer Narrative

No additional information received.Positioning on the spinal frame is intended to promote a natural lumbar lordosis.With the increased lordosis, this patient's stenosis became acute, until surgically relieved.

Event Description

From "ammar a, zarnegar r, yassari r, kinon m.Large central lumbar disc herniation causing acute cauda equina syndrome with loss of evoked potentials during prone positioning for surgery.Surg neurol int.2018 mar 19;9:66.Doi:10.4103/sni.Sni_482_17.Ecollection 2018.Pubmed pmid: 29629233; pubmed central pmcid: pmc5875114." a 56-year-old obese male presented with 7 days of low back pain radiating down both lower extremities accompanied by a mild 4/5 right foot drop.The lumbar mri demonstrated a large l2-3 central disc herniation/stenosis resulting in marked thecal sac/nerve root compression.When placed prone on a jackson table, the preoperative sep/mep baselines were completely lost.Potentials immediately returned when he was returned to the supine position.When repositioned prone, although signals were again lost, the surgeons proceeded with an emergent l2-l3 laminectomy/discectomy; by the end of the procedure, the signals returned to the baseline bilaterally.Postoperatively, the patient fully recovered.Intraoperative neurophysiologic monitoring is useful in predicting neurologic compromise in patients with significant compressive spinal pathologies.Here, it was useful in a patient exhibiting a massive l2-3 disc herniation with stenosis resulting in cauda equina syndrome.Although sep/meps were lost both times the patient was placed prone on the jackson table prior to surgery, the second time it was elected to proceed with an immediate decompression.Potentials likely dropped due to prone positioning on the jackson table - the position probably acutely increased the lumbar lordosis, exacerbated the stenosis, and increased the epidural pressure.In the future, one should consider placing such patients on a wilson frame that offers a less lordotic posture.In these situations, neurophysiologic monitoring (sep/mep) can alert the surgeon of impending neurological injury warranting urgent decompression.

• Brand Name: MTS SPINAL SURGERY TOP
• Type of Device: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 8375616
• MDR Text Key: 137313585
• Report Number: 2921578-2019-00011
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5943
• Device Catalogue Number: 5943
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR