MAUDE Adverse Event Report: SYNTHES (USA); PROTHESIS, RIB REPLACEMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following article: the vertical expandable prosthetic titanium rib implant for the treatment of thoracic insufficiency syndrome associated with congenital and neuromuscular scoliosis in young children.Hell, a., et al (2005).Journal of pediatric orthopaedics b 14: 287-293.This study evaluated the first experience of vertical expandable prosthetic titanium rib (veptr) implantation in european patients.Since 2002, 15 children with severe scoliosis and thoracic insufficiency syndrome were treated in one center with the veptr (synthes spine co., west chester, pennsylvania, usa).Eight patients were boys and 7 were girls.The mean age was 6 years (range 11 months to 12.2 years) at the time of surgery.Nine children had thoracic insufficiency syndrome due to unilateral unsegmented bars (n= 4), absent ribs (n= 1), hemivertebrae (n =2) or bilateral fused ribs (n= 2).Six children had severe thoracolumbar scoliosis and pelvic obliquity due to neuromuscular scoliosis.The surgical technique consists of a standard thoracotomy incision around the scapula with exposure of the thorax.The superior cradle was placed around stable ribs as far posterior and close to the spine as possible.At the apex of the thoracic curve one or multiple opening wedge thoracostomies were performed to enlarge and lengthen the constricted hemithorax.Distraction was applied gradually and under spinal cord monitoring.The fused ribs wee separated and the pleura was carefully stretched.After expansion thoracoplasty the veptr device was implanted to stabilize the gained correction.All surgeries were performed with spinal cord monitoring (somatosensory-evoked potentials and motor-evoked potentials).Except for the neuromuscular cases (n=6), patients received an opening wedge thoracostomy with veptr implantation and expansion thoracoplasty.Afterwards the child was monitored in an intensive care unit.Respiratory therapy is mandatory.To accommodate for later growth of the patients the device is lengthened through a minimal incision two to three times a year.In patients with neuromuscular scoliosis either an iliac crest dunn-mccarthy hook or a caudally placed laminar hook was used.In children with expansion thoracoplasty the families reported increased playing and sport activities.In the neuromuscular patients families reported better sitting abilities in the wheelchair and more stability.Three complications were reported after the veptr implantations.This report refers to patient# 9, 5.82 years old, who had skin breakage post-operatively.The authors concluded that the expansion thoracoplasty and veptr implantation method had been successful in treating hemithorax hypoplasia and seemed to be superior to other concepts in treating small children with severe scoliosis.This is report 2 of 3 for (b)(4).This report is for an unknown veptr.

Manufacturer Narrative

Device used for treatment, not diagnosis.This report is for an unknown veptr/unknown quantity/unknown lot.(b)(6).The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number were provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

• Type of Device: PROTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4579772
• MDR Text Key: 5342282
• Report Number: 2520274-2015-11493
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• 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: 02/15/2015
• 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: 6 YR