MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: VEPTR; PROSTHESIS, RIB REPLACEMENT

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Post Operative Wound Infection (2446); Nervous System Injury (2689); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: veptr/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

Event Description

This report is being filed after the review of the following journal article: bellaire, l.L.Et al (2020), growth-friendly spinal instrumentation in marfan syndrome achieves sustained gains in thoracic height amidst high rates of implant failure, journal of pediatric orthopedics, vol.Xx (xx), pages 1¿7 (usa).The aim of this prospective registry and retrospective study is to evaluate of the outcomes, including safety and efficacy, of growth-friendly spinal instrumentation in mfs patients with the hope of more clearly guiding patient expectations and identifying areas for continued innovation and progress.Between 1996 and 2016, a total of 42 patients (22 male and 20 female) with a mean age of 5.5 years (ranged from 1.3 to 12.8 years) were included in the study.Surgery was performed using vertical expandable prosthetic titanium rib (veptr) systems in 4 patients and the rest with competitor devices at index procedure.Implants were converted over the course of the study period (table 2).All patients had a minimum of 2 years follow-up after their index surgery, but follow-up averaged 6.5 (± 4.1) years.The following complications were reported as follows: 2 patients died; the first patient died of unknown causes at an outside hospital over 1 year after most recent spine surgery.The second patient had a cardiac-related death also at an outside hospital 2 years after most recent spine surgery.14 underwent a lengthening or revision surgery within the 24 months before the end of the study period.Patients underwent an average of 7.2 total surgeries (including their index procedure and final fusion, where applicable).This occurred over a variable length of time; all patients included in the study had a minimum of 2 years follow-up after their index surgery, but follow-up averaged 6.5 (± 4.1) years.Included patients underwent a mean of 4.8 lengthening surgeries (range: 0 to 17), not including in-clinic mcgr lengthenings, and 1.4 surgeries for revision or exchange (range: 0 to 10) of their growth-friendly instrumentation, not including conversion to definitive final fusion.27 patients (65%) experienced a complication, with a total of 110 complications noted.4 patients had a superficial infection, with a total of 5 incidents of this complication which required 3 unplanned surgeries and 2 were treated by antibiotics alone.6 patients had a deep infection, with a total of 9 incidents of this complication which required 7 unplanned surgeries, 1 was treated with antibiotics alone, and 1 required abandoning of growth-friendly strategies.2 patients had a wound dehiscence without infection, with a total of 2 incidents of this complication.4 patients had a pulmonary complication, with a total of 12 incidents of this complication.5 patients had a dural tear or leak, with a total of 5 incidents of this complication.Dural tears occurred intraoperatively in 4 patients due to inadvertent violation of a dural ectasia diverticulum, 1 due to adherence of dura to an osteotomy site; all were primarily repaired except 1 was treated with lumbar drain and bedrest (svi).2 patients had a feeding or gastrointestinal complication, with a total of 2 incidents of this complication.8 patients had a neurogenic symptoms, with a total of 9 incidents of this complication.1 patient had a temporary neurological deficit, with a total of 1 incident of this complication.1 patient had an arrhythmia or other cardiac event, with a total of 1 incidents of this complication.13 patients had an unspecified or other complication, with a total of 14 incidents of this complication.6 patients experienced a large fraction of these complications (=6 complications each, table 5).2 such patients had repeated bouts of pulmonary decompensation requiring reintubation and pediatric intensive care unit admissions.The other 4 had minimal medical issues but rather required multiple revisions due to hardware failures, and 3 of these 4 also experienced cerebrospinal leaks.20 patients had implant failure or migration, with a total of 48 incidents of this complication.Of these, 4 patients were treated nonoperatively (severity grade 1), 11 required a single unplanned surgery (sviia), and 5 required multiple unplanned surgeries (sviib).This report is for an unknown synthes veptr constructs.This report is for one (1) unk - constructs: veptr.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: VEPTR
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11330063
• MDR Text Key: 240286774
• Report Number: 2939274-2021-00862
• Device Sequence Number: 1
• Product Code: MDI
• 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: 01/27/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/15/2021
• 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