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

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

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); No Code Available (3191)

Event Date 09/07/2018

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: veptr/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.One patient experienced brachial plexus palsy, three patients experienced spine infections, and one patient experienced implant failure all of whom required revision surgery.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: the investigation could not be completed; no conclusion could be drawn at the time of filing this report.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: eby sf.Et al (2018), thoracogenic spinal deformity: a rare cause of early-onset scoliosis, j neurosurg spine, volume 29, pages 674-679, (usa).The purpose of this study was to evaluate and characterize patients with severe thoracogenic scoliosis from a large, multicenter database of children with early-onset scoliosis (prior to 10 years of age).Between 2002 and 2014, 41 patients who underwent a prior medical procedure or surgery on the chest wall or spine (sternotomy, thoracotomy, chest wall resection, laminectomy, or chest wall radiation therapy) and were noted to have thoracogenic scoliosis were included in the study.Of the 41 patients, 14 were observed, 10 received casts and/or braces, and 17 were treated surgically.There were 15 patients who underwent treatment using an unknown synthes vertical expandable prosthetic titanium rib (veptr), 1 underwent a shilla procedure, and 1 had growing rods implanted.All operative patients had bilateral devices placed.The operative patients included 6 males and 9 females with a mean age at scoliosis surgery of 6.6 years and a mean of 4.5 years of follow-up.Over the study period, patients underwent a mean of 7.5 surgeries (range 2¿21), including a mean of 4.75 lengthening procedures (range 0¿14).13 complications occurred in 7 patients implanted with the veptr device including the following: 5 patients had pneumonia in which 3 of them required hospitalization while the other 2 were treated on an outpatient basis.1 patient had brachial plexus palsy that was resolved with revision of the rib hooks.3 patients had a spine infection and required revision.1 patient had device migration and required revision.1 patient had implant failure 3 times and required revision.This report is for one (1) device- unknown synthes vertical expandable prosthetic titanium rib (veptr).This impacted product captures the following adverse events: pneumonia; brachial plexus, revised; spine infection, revised; implant failure.This is report 1 of 2 for (b)(4).

• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8742302
• MDR Text Key: 149481165
• Report Number: 2939274-2019-58904
• 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: 06/03/2019

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: 06/03/2019
• Initial Date FDA Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention