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 Spinal Column Injury (2081); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown of vertical expandable prosthetic titanium rib (veptr).Part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Complainant device is not expected to be returned for manufacturer review/investigation.As specific part and lot numbers for vertical expandable prosthetic titanium rib (veptr) is not provided.Patient code (b)(4) is used to capture additional medical/surgical intervention required.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

This report is being filed after the subsequent review of the following literature article: el-hawary (2017) veptr implantation to treat children with early-onset scoliosis without rib abnormalities: early results from a prospective multicenter study.Journal of pediatric orthopaedics.Volume 37(8), pages e599-e605.United states.The aim of this study was to evaluate the efficacy of vertical expandable prosthetic titanium rib (veptr) in preventing further progression of scoliosis without impeding spinal growth in children with progressive early-onset scoliosis (eos) without rib abnormalities.This study also examined the outcome of rib-based distraction (veptr) in patients with eos without rib abnormality at 2-year follow-up this is a retrospective review of a multicenter, observational cohort study conducted between january, 2007 and january, 2015 consisting of 63 patients, 35 males and 28 females who underwent veptr insertion surgery.Patient had mean age of 6.1 ± 2.4 years and the mean follow-up period was for 2.2 ± 0.4 years.Erect radiographs were analyzed for coronal and sagittal curve and height measurements at preimplant, immediate postoperative, and at 2-year follow-up.The primary outcome measure was the major scoliosis curve magnitude and coronal t1-s1 spine height at 2 years.Successful result was defined if one of these 2 criteria was met: (1) the patient¿s scoliosis magnitude at 2-year follow-up was less than or equal to the patient¿s preoperative scoliosis magnitude.(2) the patient¿s trunk height or spinal length at 2-year follow-up was greater than or equal to the patient¿s immediate postoperative trunk height or spinal length.In contrast, failure result was defined if none of these criteria was met.The following complications were recorded: scoliosis (72±18 degrees) decreased after implantation (47±17 degrees) followed by slight increase at 2-year follow-up (57±18 degrees).Kyphosis (48±22 degrees) decreased after implantation (40±14 degrees) followed by slight increase at 2-year follow-up (48±16 degrees).At 2-year follow-up period, the following radiographic parameters deteriorated: major curve cobb deteriorated in 9 patients major curve cobb (5 deg.) deteriorated in 4 patients secondary curve cobb deteriorated in 23 patients secondary curve cobb (5 deg.) deteriorated in 16 patients maximum kyphosis cobb deteriorated in 27 patients t1-t12 spinal height deteriorated in 5 patients t1-s1 spinal height deteriorated in 3 patients t1-t12 spine sagittal length deteriorated in 7 t1-s1 spine sagittal length deteriorated in 3 patients instrumented spine sagittal length deteriorated in 3 patients during the distraction phase, the following radiographic parameters deteriorated: major curve cobb deteriorated in 47 patients major curve cobb (5 deg.) deteriorated in 42 patients secondary curve cobb deteriorated in 35 patients secondary curve cobb (5 deg.) deteriorated in 25 patients maximum kyphosis cobb deteriorated in 44 patients t1-t12 spinal height deteriorated in 24 patients t1-s1 spinal height deteriorated in 18 patients t1-t12 spine sagittal length deteriorated in 10 patients t1-s1 spine sagittal length deteriorated in 9 patients instrumented spine sagittal length deteriorated in 10 patients 31 patients had at least 1 complication with total of 58 complications as listed below: device migration was noted in 15 patients pneumonia was noted in 8 patients wound problems was noted in 8 patients infection was noted in 6 patients rib fracture 3 patients hardware prominence was noted in 3 patients pain was noted in 3 patients respiratory distress 3 patients hardware failure was noted in 2 patients respiratory symptoms was noted in 2 patients gastrointestinal disturbance was noted in 2 patients pneumothorax was noted in 1 patient febrile seizures was noted in 1 patient neurological symptoms was noted in 1 patient this report is for an unknown of vertical expandable prosthetic titanium rib (veptr) a copy of the literature article is being submitted with this medwatch.This is report 1 of 1 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: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7294235
• MDR Text Key: 100889379
• Report Number: 2939274-2018-50766
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2018
• 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: 01/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention