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 Unspecified Infection (1930); Spinal Column Injury (2081); Weakness (2145); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown - veptr implants/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 and surgical intervention.For surgical intervention, infection, dura tear, spinal disorder (myelopathy), paresthesia, kyphosis, implant prominence (medical device site reaction) and weakness.The article groups complications into groups, this represents wound and medical/ surgical complications.The article does not directly state the following occurred but it lists them as examples.Conservatively this will be reported for these complications without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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: bachabi m.Et al (2018), idiopathic early-onset scoliosis: growing rods versus vertically expandable prosthetic titanium ribs at 5-year follow-up, j pediatr orthop, volume 00, number 00, pages 1-7, (usa).The purpose of this study was to evaluate long-term clinical and radiographic results of traditional growing rods (tgr) versus vertically expandable titanium ribs (veptr) treatment for idiopathic eos.From 1993 through 2009, 50 patients treated with a competitor¿s traditional growing rods (tgr) and 22 patients treated with an unknown synthes vertically expandable titanium ribs (veptr) for an idiopathic early-onset scoliosis (eos) with a minimum of 5-year follow-up after the initiation of ¿growth-friendly surgery¿, and with 4 or more lengthening were included in the study.11 patients received unilateral veptr constructs and 11 patients received bilateral veptr constructs.The mean age at the time of the initial procedure for the veptr patients was 4.3 years with a mean follow-up duration of 7.7 years.Complications were evaluated and were categorized as medical/surgical (ie, postoperative cardiopulmonary or gastrointestinal complications, dural tears, myelopathy, paresthesia, postoperative weakness), or as related to the wound (ie, superficial infection, deep infection), the implant (ie, rod breakage, anchor failure, implant prominence), or alignment (ie, proximal junctional kyphosis of at least 10 degrees or 10 degrees greater than preoperative measurement).Complications were reported as follows: (unilateral veptr)- 6 patients had implant-related complications.4 patients had wound-related complications.(bilateral veptr)- 9 patients had implant-related complications.5 patients had wound-related complications.2 patients had medical or surgical related complications.Unknown patients had major kyphosis progressed to a greater extent (mean, 31 degrees).This report is for one (1) device- unknown synthes vertical expandable prosthetic titanium rib (veptr).This impacted product captures the following adverse events: major kyphosis progressed to a greater extent.Wound-related complication.Medical or surgical related complications.This is report 2 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: 8746449
• MDR Text Key: 149641825
• Report Number: 2939274-2019-58926
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• 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: 06/04/2019
• 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