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 Wound Dehiscence (1154); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: john t.Smith (2016), bilateral rib-based distraction to the pelvis for the management of congenital gibbus deformity in the growing child with myelodysplasia, spine deformity vol.4(1), pages 70-77 (usa).The aim of this study is to report our intermediate-term outcomes in four patients with gibbus deformity treated with a rib-to-pelvis distraction technique.A total of 4 patients (2 males and 2 females) with a mean age of 20 months (ranges, 16-25 months) were included in the study.These patients were managed with bilateral rib-to-pelvis distraction using the veptr device and expansions of devices at 6-month intervals.The mean duration of follow-up was 66 months (ranges 48-84 months).The following complications were reported as follows: a (b)(6) year-old patient 1 had 2 infections and 2 migrations of bilateral veptr.A (b)(6) month-old patient 2 had 2 infections/wound dehiscence of bilateral veptr.An (b)(6) month-old patient 3 had 2 device migration and 1 dural leak of bilateral veptr.A (b)(6) year-old patient 4 had 1 wound dehiscence of bilateral veptr.This is report 3 of 6 for (b)(4).This report is for an unknown synthes veptr.

• 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: 8880056
• MDR Text Key: 153886444
• Report Number: 2939274-2019-59667
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• 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: 07/15/2019
• 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: 15 MO