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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following article: the role of the vertical expandable titanium rib in the treatment of infantile idiopathic scoliosis early results from a single institution schulz, j., et al (2010).J pediatric orthop 30:7 659-663.Usa article.This was a retrospective study to identify children treated between 2000 and 2009 with vertical expandable prosthetic titanium rib (veptr, synthes, west chester, pa) for correction of infantile idiopathic scoliosis.The study group consisted of 8 patients (3 boys, 5 girls) with an average age at diagnosis of 14 months (range: 4 to 30 months).Patients were excluded from the study if they had congenital anomalies.The aim of the study was to review the clinical and radiographic outcomes of patients treated at a single institution with the veprt device for management of progressive curves that were unresponsive to, or too aggressive for, less invasive treatment.The following radiographic measurements were taken from pretreatment, initial post-treatment, and most recent follow-up radiographs: initial rib vertebral angle difference (rvad), cobb angles in the coronal and sagittal planes, spinal lengths from t1 to s1, and sagittal balance measured as deviation from a c7 plumb line.Of the 8 patients, 5 underwent a trial of bracing and 2 more underwent vertebral body stapling (vbs) of 4 levels in an attempt to control curve progression before placement of the veprt.The average duration of follow-up was 32 months (range: 14 to 45 months).Patients were generally evaluated every 4 to 6 months with standard posterior anterior and lateral full-spine, standing radiographs.The average age at the time of surgery was 45.8 months (range 24 to 84 months).The average preoperative cobb angle was 84 degrees (range: 50 to 119 degrees) and showed mean curve correction of 35.1% (range: 20% to 60%) over an average follow-up of 32 months (range: 14 to 45 mo.).Spinal height increased a mean of 71mm (range: 51 to 98 mm) over an average of 4 lengthenings (range: 2 to 7).Three of 8 patients (37%) had hardware complications necessitating replacement.Patient number 1 had erosion of the proximal hooks through the ribs requiring replacement at the time of the fifth lengthening.Patient number 4 had migration of the pelvic clamps requiring replacement and eventually placement of pedicle screws at the third and fourth lumbar vertebrae to allow for more effective lengthening.Patient number 6 underwent replacement of slipped pelvic clamps at the second lengthening and replacement of the proximal rib hooks at the fourth lengthening.The authors concluded that the vertical expandable prosthetic titanium rib device was a safe and effective treatment option for large-magnitude curves in the unique patient population involved in the study.However, given the limitations of the study (small size and lack of long-term follow-up) they thought that larger, long term studies were necessary to further clarify the exact role this new modality in the treatment of infantile idiopathic scoliosis.This is report 3 of 3 for (b)(4).This report is for patient #6 for an unknown veptr.

Manufacturer Narrative

Device used for treatment, not diagnosis.This report is for an unknown veptr/unknown quantity/unknown lot.(b)(4).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: 4602563
• MDR Text Key: 5469379
• Report Number: 2520274-2015-11609
• 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: 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: 03/16/2015
• Is this an Adverse Event Report?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 24 MO