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

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following online journal abstract, ¿operative treatment of scoliosis with the use of veptr: our experience¿ (2011).Fairbank, j., macdonald, j.W., nnadi, c., and pyrovolou, n.British editorial society of bone and joint surgery.A retrospective study of 8 children treated with vertical expandable prosthetic titanium rib (veptr) for correction of early onset spinal scoliotic deformities was performed at a spinal orthopaedic department at a hospital in (b)(6).Eight children with progressive scoliosis due to a variety of conditions: six congenital (two goldenhar syndrome, two vacterl syndrome, two congenital thoracic abnormalities), one spondyloepiphyseal dysplasia, one early onset of scoliosis, underwent the index procedure and subsequent lengthening procedures at six months intervals (one patient had 11 lengthening procedures).Mean age was 4 years (2-6 years) and mean follow up 3.8 years (2-6 years).Mean preoperative cobb angle was 64,8° (51-108) and mean postoperative angle 40° (31-50).Three patients developed infection with wound breakdown.One patient underwent removal of one of the two veptr rods.In the other two patients the rods were removed followed by antibiotics and the veptr converted to another growing rod system.Overall, patients tolerated the multiple procedures well.Three patients experienced significant distress with multiple surgical procedures.It was concluded that veptr offers a viable treatment option for children with severe congenital and early onset scoliosis where there are no viable alternatives.Complication rate is acceptable in view of the benefits.None of the complications have lead to long term complications to date, but the repeated lengthening have resulted in psychological disturbance which we are investigating further.There is not sufficient information to file multiple reports.This refers to an unknown veptr construct.

Manufacturer Narrative

Device for treatment, not diagnosis.¿operative treatment of scoliosis with the use of veptr: our experience¿ (2011).Fairbank, j., macdonald, j.W., nnadi, c., and pyrovolou, n.British editorial society of bone and joint surgery.This report is for an unknown veptr construct/ unknown lot.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PROSTHESIS, 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: 3761781
• MDR Text Key: 4421490
• Report Number: 2520274-2014-10916
• 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: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention