MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number MSB_UNK_SCREW

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Post Operative Wound Infection (2446)

Event Date 12/01/2008

Event Type  Injury  

Event Description

Summary: a retrospective review study to evaluate the safety and efficacy of iliac screws as a method of pelvic fixation in neuromuscular spinal deformity.All patients with the diagnosis of neuromuscular scoliosis operatively managed with iliac screws undergoing posterior spinal fusion were retrospectively identified over a 32-month period, from (b)(6) 2002 to (b)(6) 2005.Evaluation was done for correction of deformity, progression, instrumentation failure, and complications.Progression was defined as an increase in cobb angle >5 degree.Of the 14 eligible patients, 12 (86%) had adequate follow-up, with an average final follow-up of 19.5 months (range, 12-39 months).There were no incidences of rod breakage, and there was 1 iliac screw offset connector dislodgement from the rod, which did not require revision.There were no intraoperative complications.There were 3 postoperative wound infections, which required irrigation and debridement and eventually resulted in fusion.In conclusion, this is one of the largest reports of iliac screw use in the correction of neuromuscular scoliosis.Method: primary diagnoses included cerebral palsy in 11 patients and spinal motor atrophy in 1 patient.Three patients had additional diagnoses of rett syndrome, triple x chromosome syndrome, and meningitis.Indications for surgery included unsuitable sitting posture caused by sagittal and coronal imbalance, pelvic obliquity preventing a balanced sitting posture, and/or progressive kyphoscoliosis compromising respiratory function.All patients underwent posterior-only instrumented fusion.Average patient age at surgery was 15 years.Eleven patients underwent posterior spinal fusion from t2 to pelvis, and 1 patient underwent fusion from t3 to pelvis.Average estimated blood loss for all patients was 1091 ml, and average surgery time was 330 minutes.Patients were transferred to the pediatric intensive care unit postoperatively.They received antibiotics for a minimum of 48 hours.They were transferred to the floor when deemed stable by the primary surgeon and pediatrician.Mobilization was permitted as soon as possible with skilled assistance.No brace was prescribed postoperatively.Medical records and operative reports were reviewed for all patients.Operative time, estimated blood loss, patient¿s age at surgery, neuromuscular disorders, and indications for surgery were reviewed.Medical complications including neurologic injury, wound infection, urinary tract infections, and pulmonary compromise were assessed.Radiologic assessment included review of sitting long-cassette anteroposterior and lateral spine radiographs obtained preoperatively, immediately postoperatively, and at most recent follow-up.Correction and progression of deformity and instrumentation failure were recorded.Results: significant correction of coronal cobb deformity was obtained; average correction was 43.7degree.Average sagittal l5-s1 angle was 31degree on initial postoperative radiographs and 26 degree at most recent follow-up.Perioperative complications in the series included 1 dislodged iliac screw connector and 3 wound infections.There were no neurologic insults.The hardware failure was treated conservatively and was later removed when radiographic fusion was confirmed.The wound infections were treated in standard fashion including culture-sensitive antibiotics and multiple irrigation and debridements.These complications did not lead to a long-term failure of treatment.

Manufacturer Narrative

D1, d4, g3: product identifiers are unknown b3: date when the article was published (month : year is valid).Digital sharing of the article would be in violation of copyright permission citation: alex gitelman, samuel a.Joseph jr, wesley carrion, <(>&<)> mark stephen.Results and morbidity in a consecutive series of patients undergoing spinal fusion with iliac screws for neuromuscular scoliosis.Feature article december 2008 | volume 31.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: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 16866112
• MDR Text Key: 314526800
• Report Number: 1030489-2023-00331
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCREW
• Device Catalogue Number: MSB_UNK_SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• 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