MAUDE Adverse Event Report: SYNTHES; UNKNOWN

Catalog Number UNK - VEPTR

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article ¿bilateral rib-to-pelvis eiffel tower vertical expandable prosthetic titanium rib (veptr) construct for children with neuromuscular scoliosis: a preliminary report.¿ twenty neuromuscular scoliosis patients (8 boys and 12 girls) received percutaneous bilateral rib-to-pelvis veptr implantation, also known as the ¿¿eiffel tower¿¿ construct as a method of correction of their spinal deformity through a relatively minimally invasive technique.All patients were treated at a single institute, between october 2005 and july 2009.The mean age at surgery was 8.9 ± 2.2 years ranging from 4 to 12 years.The major curve was the lumbar curve in 10 patients, thoracolumbar in 9, and thoracic in 1 (69°).The surgical technique involved six small incisions, a modification to smith technique that uses three midline incisions to insert implants on both sides of the midline, where the upper cradle was attached to the second to fourth ribs, and the iliac hook and the locking mechanism were inserted and connected through a subfascial tunnel on both sides of the spine.The rod parts of the veptr implants were contoured to ensure maintenance of the lumbar lordosis.In this group, 9 of 20 patients (45%) suffered complications.Eighteen complications occurred in relation to 20 primary veptr implantations and 39 lengthenings, an incidence of 30.5% per procedure.Minor complications included five proximal cradle migrations (cut-through ribs), four broken iliac hooks, two dislodged iliac hooks, and one hybrid implant failure.These complications were addressed during the subsequent lengthening procedure scheduled every 6 months, as there was no threat to the overlying soft tissue or acute loss of balance in these patients.Pain was reported in a child with cerebral palsy after the primary implantation and was thought to be because of lumbar plexus irritation by the iliac hooks.Revision and strict subperiosteal insertion of the pelvic hooks were performed with the subsequent lengthening procedure, and pain was relieved.One patient with spinal muscular atrophy suffered twice from bilateral pelvic hook dislodgment, in a windblown fashion, with resultant acute loss of his sitting balance, which was revised as a nonelective surgery both times with reinsertion of the iliac hook at a fresh area of the iliac crest, regardless of his distraction schedule.Deep wound infection occurred in three patients, one of them having had a poor skin condition with very little subcutaneous tissue and developed a decubitus ulcer.Those three wounds were treated immediately by irrigation and debridement, extracorporeal sterilization of the implant, and refixation.The infection did not recur in these three patients, and the implant could be retained.One wound slough was treated surgically by wider skin mobilization and delayed primary closure.The rate of complications in this group of 20 patients was relatively high compared with other reports (30.5% per procedure), but only in 6 incidents was it necessary to intervene with a nonelective surgical procedure.The other 12 complications were treated at the following elective lengthening procedure by implant exchange or reinsertion at a more appropriate anchor point.A higher complication rate, especially related to weak bone, is expected in this group of patients.The authors concluded that it is appropriate to use veptr eiffel tower construct for the management of nonambulatory children with neuromuscular scoliosis.This report is 4 of 5 for com # (b)(4).

Manufacturer Narrative

The device was used for treatment, not diagnosis.Mean age 8.9±2.2 years ranging from 4 to 12 years.8 males and 12 females.Weights not provided.This report is for unknown veptr, unknown part number and unknown lot number.Oyoun, n.& stuecker, r.(2013).Bilateral rib-to-pelvis eiffel tower veptr construct for children with neuromuscular scoliosis: a preliminary report.The spine journal, 1-9.Without a lot number the device history records review could not be completed.The investigation could not be completed; therefore, no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: UNKNOWN
• Manufacturer (Section D): SYNTHES; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3771333
• MDR Text Key: 4430493
• Report Number: 2520274-2014-11027
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNK - VEPTR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2014
• 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