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

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

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Event Description

This report is being filed after subsequent review of the following abstract; maredi (2014): efficacy and safety of growing spinal systems in the treatment of hyperkyphosis in early onset deformity.Eur spine j 23 (suppl 5) s500.Italy.The authors retrospectively reviewed 18 paediatric patients affected by kyphotic spinal deformity (t3-t12 kyphosis >60) surgically treated with growing rod or veptr-like systems from 2007 to 2014.The etiology:idiopathic (5), kyphosis in morquio (1) and in pott disease (1), congenital scoliosis (4), trisomy 8 (1), escobar syndrome (1), prader willi (1), spondylocostal dysplasia (1), arthrogryposis (3).There were 9 males and 9 females, with a mean age of 7 years.Dual growing rod was implanted in 9 cases, veptr in 11 (always rib to spine construct).Pre-operative main thoracic scoliosis averaged 67 degrees, lumbar scoliosis 55 degrees and thoracic kyphosis 73 degrees, 67 degrees in patients treated with growing rod and 77 degrees for those treated with veptr.Follow up (range 6 months to 7 years).After first surgery, thoracic kyphosis was corrected from a mean value of 73 degrees to 52 degrees; in cases treated with growing rod, kyphosis was corrected from 67 degrees to 44 degrees, in cases treated with veptr from 77 degrees to 60 degrees.At final follow up, after 31 lengthening procedures, a loss of correction occurred on sagittal plane:thoracic kyphosis increased from 52 degrees to 59 degrees; in case of growing rod, from 44 degrees to 50 degrees, in case of veptr from 58 degrees to 68 degrees.This report refers to 15 minor complications occurred in 7 patients, requiring revision surgery in 7.This is report 1 of 1 for (b)(4).This report is for an unknown veptr, unknown part#/lot# and unknown quantity.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Maredi (2014): efficacy and safety of growing spinal systems in the treatment of hyperkyphosis in early onset deformity.Eur spine j 23 (suppl 5) s500.Italy.This report is for unknown veptr/unknown quantity/unknown lot.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.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: 4598922
• MDR Text Key: 5467265
• Report Number: 2520274-2015-11426
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/24/2015

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?: Yes
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 03/13/2015
• 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