MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

Model Number MSB_UNK_BMP2_ACS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/28/2023

Event Type  Injury  

Manufacturer Narrative

A2: please note that the age is based off average age of patient involved in this event a3: please note that the gender is based off as per the majority of patients.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: product identifiers are unknown.D section 6a: implant date unknown.H6: 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.K.Aaron shaw, kendall anigian, daniel j.Sucato."postoperative ct imaging to characterize fusion in pediatric and adolescent vertebral column resection".Springer natural journal.(2024) 12:403¿410 https://doi.Org/10.1007/s43390-023-00775-x.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Summary: vertebral column resection (vcr) is a powerful corrective technique for the management severe, rigid spinal deformities but does carry a relatively high complications rate.A retrospective review of a single surgeon series of posterior-only vcr performed for severe pediatric and adolescent spinal deformities was performed.Demographic, radiographic, and clinical data were collected.Patients underwent postoperative ct imaging at the osteotomy site 6¿9 months following vcr with grading of the osteotomy fusion.Reported events: a total of 33 patients (mean age 11.6 ± 4.9 years, 54.5% female) were identified with all patients meeting inclusion criteria.Intraoperative neuromonitoring (ionm) was performed for all patients using somatosensory-evoked potentials, transcranial motor evoked potentials, with descending neurogenic incorporated when baseline transcranial motor evoked potentials where unable to be obtained or in situations of critical intraoperative neuromonitoring changes.Temporary rod stabilization was performed during the resection and transitioning to final rods at the completion of the resection.All patients underwent autologous bone grafting (from the resected sight) with nearly routine use of an anterior titanium mesh cage and recombinant bone morphogenic protein-2 (rhbmp-2) augmentation at the osteotomy site.Correction with a standard dual rod construct and segmental pedicle screw fixation was used in all cases.Rod size and metal type were specifically chosen for each case.For patients undergoing extension of the fusion and instrumentation into the cervical spine, a halo vest was used to augment fixation postoperatively and maintained for 3 months.Following hospital discharge, patients were assessed at standard intervals of 6 week, 3 months, 6¿9 months, 1 year and thenyearly following surgery.The most common deformity treated was kyphoscoliosis (n = 25, 75.7%) with 60.6% of the patients (n = 20/33) having undergone at least one previous spinal procedure for the spinal deformity.These patients underwent a mean 3.0 prior surgeries.Patients underwent a mean 1.9 level vcr with the majority of patients being treated with a schwab 6 osteotomy.An anterior titanium mesh age was used in 72.7% patients (n= 24/33) with younger patients having either rib structural graft or morselized graft.Bmp-2 was used to augment fusion in 69.7% of patients (n= 23/33) with the remaining being treated with a combination of autograft and allograft bone (n= 10/33).The mean major deformity correction was 54.5.The most common intraoperative complication was critical ionm alerts (36.4%,n= 12/33) which required case abortion and unplanned staged surgical intervention in four patients (12.1%).No patient had permanent neurologic deficit following surgery.Overall, there were 11 patients (33.3%) who underwent unplanned reoperation in which 4 for vcr completion following case abortion related to ionm changes, 2 for distal junctional kyphosis treated with revision psf, 2 for surgical site infections, 2 for wound dehiscence treated with revision psf, 2 for pseudoarthrosis treated with revision psf and fixation augmentation with a central rod-hook construct, and 1 for hemothorax treated with chest tube insertion.Other patient complications included 3 patients had excessive blood loss (more 2000ml), 1 patient suffered dural tear, 1 patient had pleural effusion.Surgical site infections for the patient are as follows- superficial 2 (4.0%), deep 2 (6.0%), wound dehiscence 5 (15.2%).Postoperatively, 22 patients (66.7% of cohort) underwent ct imaging at the osteotomy site at a mean of 7.8 months following surgery.Of the patients, two were identified as having an impending pseudarthrosis.Of the two pseudarthrosis cases, one patient refused to have a revision procedure and subsequently developed implant failure which is further outlined below (patient 1).The remaining patient underwent a prophylactic revision surgery and is further detailed below (patient 2).An 11year-old male (patient 1) with a past medical history significant for congenital scoliosis associated with vacterl syndrome.His presenting radiographs demonstrated a severe kyphoscoliotic deformity of the thoracic spine with 66° coronal plane and 102° sagittal plane deformities.Patient underwent a schwab grade 6 vcr including complete resection of t8 with partial resection of t7 and t9, in conjunction with a posterior spinal fusion (psf) from t2 to l2.His case was complicated by a critical alert in ionm demonstrating a significant motor amplitude drop.A recommendation was made for prophylactic revision surgery.Two months later, the patient experienced a pop in his back with increasing back pain after sneezing.Radiographs demonstrated fractured rods at the level of the osteotomy and he was indicated for revision psf with bone grafting and fixation augmentation with a central rod-hook construct.The patient did well following surgery with return to full activities.A 13-year-old male (patient 2) presented to evaluation of congenital scoliosis consisting of a fully segmented t11 hemivertebra resulting in kyphoscoliosis.Radiographs demonstrated a 92° coronal plane and 86° sagittal plane deformity, resulting in coronal and sagittal imbalance without neurologic symptoms.They were indicated for schwab grade 6 vcr of the t11 hemivertebra with partial resection of t12 and l1 with psf t6-l4.An anterior titanium mesh cage was used at the resection sitewith rhbmp-2 augmentation.The patient did well postoperatively, however, ct scan obtained 6.8 months following surgery demonstrated an impending pseudarthrosis at t10-11 with grade 4 anterior fusion.On the basis of ct imaging, a recommendation was made for revision surgery in the form of revision psf, bone grafting with fixation augmentation using a central rod-hook construct.The patient tolerated the procedure well and proceed with clinical union with most recent radiographs 8 years following surgery demonstrating maintained deformity correction.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
• 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: 19044512
• MDR Text Key: 339433410
• Report Number: 1030489-2024-00244
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_BMP2_ACS
• Device Catalogue Number: MSB_UNK_BMP2_ACS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/04/2024
• 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): Required Intervention
• Patient Age: 11 YR
• Patient Sex: Female