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

Device Problem Failure to Osseointegrate (1863)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This report is being filed after the subsequent review of the following article: veptr in patients with a previous spinal fusion.Sturm, p., et al (2007).J child orthop1: 255-276.This report is being filed after the subsequent review of the following article: surgical complications in early onset scoliosis.Phillips, j., et al (2007).J child orthop 1: 255-276.Spinal fusion had been the mainstay of treatment for children with complex congenital scoliosis.This treatment had an unintended deleterious effect on spinal growth and pulmonary development.The use of the veptr in these patients has been shown to control curve progression while allowing for trunk growth and further lung maturation.This study looks at the use of a veptr in patients who had undergone a spinal fusion.Seventeen patients who had previous spinal fusions, and then subsequently underwent the insertion of a veptr between september 1996 and february 2003, were identified among patients entered prospectively into a database for an fda ide study.Pre and postoperative cobb angle, thoracic height and complications were recorded.Eight to twelve month follow up data was available for 12 patients and 36 month follow up in 7.The indication for veptr in these patients was a progressive curve despite previous fusion, and persistent thoracic insufficiency.Average age at veptr insertion was 6 years and 7 months.Average preoperative cobb angle was 59° (range 10¿95°).Average postoperative curve measured 49° (range 5¿80°).In the subgroup with one year follow up the average preoperative cobb angle was 58.3°, postop 41.6°, follow up 48.7.The average change in trunk height was 0.74 cm at index surgery.Seven patients had complications.This included three patients with loss of fixation alone, one patient with a postoperative infection, two patients with both an infection and loss of fixation, and one patient with postoperative horner¿s syndrome.The use of a veptr has been shown to be beneficial in children with thoracic insufficiency due to various etiologies.In patients who have already had a spinal fusion the goals of veptr implantation are to improve truck deformity, expand the chest, and modulate the spinal deformity when possible.The amount of correction of both the cobb angle and thoracic height is less than in children who have not undergone a prior spinal procedure.In addition, the complication rate is higher.It should be viewed as a salvage procedure in this group of patients.This report refers to three patients with loss of fixation alone.This report is 2 of 3 for (b)(4).This report is for unidentifiable patients for an unknown veptr.

Manufacturer Narrative

Device used for treatment, not diagnosis veptr in patients with a previous spinal fusion.Sturm, p., et al (2007).J child orthop1: 255-276.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.

• 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: 4594470
• MDR Text Key: 5453659
• Report Number: 2520274-2015-11729
• 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: 03/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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