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 the subsequent review of the following literature abstract: ventura: spinal stabilization in intermediated spinal atrophy patients (sma).A review of 46 living cases.(abstracts from the 3rd international congress on early onset scoliosis and growing spine, 20¿21 november 2009, istanbul, turkey), pg 530.This retrospective review included 43 living patients with spinal muscular atrophy (sma) having undergone surgical correction of their spinal deformity between 1990 and 2008.Two groups were distinguished with respect to the technique of surgical intervention.Group i, 30 patients underwent posterior fusion t.3 to the pelvis or to l.5, average follow up 9 years (2¿18).Group ii, 16 patients treated with fusionless surgical techniques (10 growing rods, 6 vertical expandable prosthetic titanium rib (veptr) average follow up 3 years (2¿8).Group i, mean age 11 years, operative time 5 h, 3.7 units of blood, 3 average icu stay, 16 average hospital stay.Mean preoperative radiograph: thoracolumbar curves 838 (658¿1518), 60% correction; lumbar 808 (508¿1058), 52% correction; thoracic 528 (408¿938), 47% correction.Pelvic obliquity 258 (18¿448) 71% correction.Twenty-four patients had fixation to the pelvis (galveston/ iliac screw), 6 cases had fixation to l.5.Group ii, mean age 7 years, operative time 2.5 h, 0.7 units of blood, 1 average icu day stay and 9 average hospital stay.Mean pre-operative radiographs: thoracolumbar curves 908 (738¿1088), 60% correction, thoracic curves 768 (708¿1008), 46% correction, pelvic obliquity 258 (68¿358), 51% correction.Group ii, 2 (15%) cases required removal of implants.This report refers to complications with group ii.2 patients that needed removal of implants due to unknown reasons.This is report 1 of 1 for (b)(4).This report is for an unknown veptr, unknown part#/lot#.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Ventura: spinal stabilization in intermediated spinal atrophy patients (sma).A review of 46 living cases.(abstracts from the 3rd international congress on early onset scoliosis and growing spine, 20¿21 november 2009, istanbul, turkey), pg 530.This report is for 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 was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.

• 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: 4599039
• MDR Text Key: 5470309
• Report Number: 2520274-2015-11424
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2015

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: 04/13/2015
• Initial Date FDA Received: 03/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2015
• 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