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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown (veptr) construct/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: john a.Heflin et, al (2014), use of rib-based distraction in the treatment of early-onset scoliosis associated with neurofibromatosis type 1 in the young child, spine deformity vol.3(3), pages 239-245 (usa)http://dx.Doi.Org/10.1016/j.Jspd.2014.10.003.The aim of this article is to determine the effectiveness of rib-based distraction for managing scoliosis in the growing child with neurofibromatosis and to report the incidence of complications when using rib-based distraction systems.A total of 12 patients (8 males and 4 females) with a mean age of 6.34 years (range, 1.76 ¿ 11.78 years) were included in the study.These patients had progressive spinal deformity associated with nf-1 (neurofibromatosis type 1) and were treated with vertical expandable prosthetic titanium rib instrumentation (veptr).The mean duration of follow-up was 5.20 years.The following complications were reported as follows: a (b)(6) years-old male patient experienced otitis media, persistent cough, fever and device migration and was treated during hospitalization and underwent planned revision.A (b)(6) years-old male patient experienced 2 device migration and underwent planned revision.An (b)(6) years-old male patient had device migration and underwent planned revision.A (b)(6) year-old male patient experienced neurogenic pain and was resolved without treatment, the patient had hardware failure, and 3 wound dehiscence and was treated with unplanned surgery.(rod breakage).A (b)(6) years-old female patient had a hardware failure and was treated with unplanned surgery.(rod breakage).A (b)(6) years-old female patient had a right pneumothorax which was hospitalized for treatment and curve progression and was treated with unplanned surgery.A (b)(6) years-old female patient had a device migration and underwent planned revision.A (b)(6) years-old female patient had a device migration and underwent planned revision.This is report 7 of 9 for (b)(4).This report is for a vertical expandable prosthetic titanium rib (veptr) rod.

• 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: 8780481
• MDR Text Key: 150706738
• Report Number: 2939274-2019-59120
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2019
• 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
• Patient Age: 9 YR