MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREW/ROD CONSTRUCT ACCESSORIES: AXON; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Wound Dehiscence (1154); Stroke/CVA (1770); Dysphagia/ Odynophagia (1815); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes synapse/unknown lot.Part and lot numbers are unknown; udi number is unknown.Additional product codes: kwp, max.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: martinez e., et al (2016), occipitocervical fixation: a single surgeon¿s experience with 120 patients, neurosurgery volume 79, number 4, pages 549¿560 (usa).This study aims to represent the largest single-surgeon occipitocervical fusion case series to date.Clinical indications, surgical technique, and long-term clinical and radiographic outcomes are described.Between 2004 and 2013, a total of 120 patients (64 male and 56 female) mean age was 39.9 years (range, 7 months to 88 years) who were treated with occipitocervical fixation and fusion were included in the study.Multiple spinal instrumentation systems were used for occipitocervical fixation.Most frequently used were synthes synapse (synthes, inc, west chester, pennsylvania) and synthes axon (synthes, inc).The mean clinical and radiographic follow-up time was 34.6 6 27.6 months (range, 0-123 months).The following complications were reported as follows: one patient had poor neurological status on admission, experienced neurological deterioration after a vertebral artery injury that was complicated by a brainstem stroke and subarachnoid hemorrhage, and remained unresponsive after surgery (recovery rate, 233%).The greatest increases in mjoas scores and recovery rates were seen in patients who presented with hardware failure, followed by those with inflammatory arthropathies and congenital abnormalities; all reached statistically significant differences between their preoperative and follow-up status (p =.03, p,.01, and p,.01, respectively).Decline neurological status (mjoas change) in 1 patient postoperatively.Decline neurological status (mjoas change) in 1 patient at last follow-up.Unchanged (mjoas 6¼ 18) in 3 patients postoperatively unchanged (mjoas 6¼ 18) in 2 patients at last follow-up.Patients presenting with infections or vascular or multiple causes did not have a statistically significant change.Accurate neurological exams could not be obtained in 3 of these patients (5%) due to severe traumatic brain injury.Of the 22 patients with sci, 8 (36%) remained unchanged.3 ais-c: motor (#2/5) incomplete spinal cord injury at last follow-up neurological status.8 ais-d: motor ($3/5) incomplete spinal cord injury at last follow-up neurological status.Patients who presented upper cervical spine metameric avm left-hemispheric cerebrovascular accident secondary to embolization, cushing syndrome had mild neck pain at last follow-up.Strength: right ue 41/5, right le.Patients who presented with dwarfism, jra, and hardware failure; incidental right va pseudoaneurysm and absent left va, numb was wheelchair-bound, mild neck pain and wheelchair-bound, no pain at last follow-up.Sensation: numb postoperative and strength: ue 31/5 and le 3/5 incontinent postoperatively and at last follow-up.Patients who presented multiple congenital abnormalities, hardware failure, spinal cord tethering, suboccipital craniectomy, and multiple vp shunt failures has quadriplegic, gcs score: 6 postoperatively and quadriplegic, gcs score: 8 at last follow-up.Pseudarthrosis was detected in 1 patient on pet-ct.Fusion ultimately occurred after surgical revision.Neurological deterioration and long-term sequelae from the injury developed in only 1 of the patients with a vertebral artery injury.There were 13 complications in 12 patients associated with the surgical procedure, including 4 patients (3%) who experienced intraoperative complications.4 patients (3%) with wound dehiscence.2 (1.7%) with wound infections.1 (0.8%) with transient dysphagia.A rod fracture ina second patient was also likely caused by pseudarthrosis, despite ct findings of positive arthrodesis.Fusion ultimately occurred after surgical revision.1 patient presented with pain secondary to a broken rod 18 months postoperatively.Ct imaging demonstrated solid arthrodesis, but given the presence of rod fracture and imperfect evaluation of fusion seen on ct, pseudarthrosis was still likely responsible.One patient with severe traumatic atlantoaxial dislocation died 5 days postoperatively of hospital-acquired pneumonia and sepsis.Of the remaining 21 patients, 12 were confirmed to be deceased at the time of chart review.A patient had a wound infection developed postoperatively that required wound debridement and antibiotic treatment that ultimately resolve completely.She was discharged to subacute rehabilitation in good clinical condition with 4 6 5 strength throughout.Despite appropriate measures, the patient experienced progressive clinical deterioration and died 2 months postoperatively.1 patient presented 12 months postoperatively with sublaminar wire fracture and pseudarthrosis, which was confirmed on pet-ct imaging.(hardware failure).This is report 2 of 8 for (b)(4).This report is for an unknown synthes axon.

• Brand Name: UNK - SCREW/ROD CONSTRUCT ACCESSORIES: AXON
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9078060
• MDR Text Key: 161980050
• Report Number: 2939274-2019-60639
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention