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 Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown veptr construct/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date between october 2001 and october 2004.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: smith, m.D.And campbell, r.M.(2006), use of a biodegradable patch for reconstruction of large thoracic cage defects in growing children, journal of pediatric surgery, vol.41 (1), pages 46-49 (usa).The aim of this prospective study is to evaluate the use of sis in the treatment of significant chest wall soft tissue defects in the growing child, be congenital or acquired during the treatment process.Between october 2001 to october 2004, a total of 26 patients (9 females and 17 males) with age ranged from 12 months to 13 years old, were included in the study.Surgery was performed using vertical expandable prosthetic titanium rib (veptr).The following complications were reported: 2 patients had 2 deep wound infections owing to staphylococcus aureus.3 patients had very superficial epidermal wound dehiscences, requiring minimal, local wound care.3 patients had positive tracheostomy site cultures, one each of pseudomonas species, hemophilus influenza, and ¿-hemolytic streptococcus.One patient (no.7) had 2 episodes of significant wound infection on march 23, 2004, and november 2, 2004, each requiring extensive debridement in the operating suite.Each time, the organism was s aureus; for this reason, the deep tissues were biopsied to look at the integrity of the sis.On march 23, 2004, the histological interpretation was a 0.5x0.3x0.2 cm of white material with no evidence of inflammation.Biopsy was again done on november 2, 2004, at the second infection, showing skeletal muscle from the intercostal area, negative for fibrosis, inflammation, or atrophy.The patients continue to improve from the respiratory standpoint.This report is for an unknown synthes vertical expandable prosthetic titanium rib (veptr).This is report 2 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8753501
• MDR Text Key: 149803495
• Report Number: 2939274-2019-58966
• 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: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• 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: 06/05/2019
• 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