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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

This report is being filed after subsequent review of the following abstract: greggi (2014): early onset scoliosis (infantile idiopathic scoliosis and magnetically controlled dual growing rod).Eur spine j, 23 (suppl 5) s500.Italy.The authors retrospectively reviewed 7 patients, affected by infantile idiopathic scoliosis surgically treated with magnetically controlled growing rods (mcgr), minimum follow up 6 months.In all cases a dual growing rod was implanted, using pedicle screws as distal anchors, hooks as proximal anchors.The study included 7 children, 3 females and 4 males, with an age ranging from 4 to 11 years.The aetiology was 6 idiopathic (infantile or juvenile), 1 congenital.In one case a veptr was first implanted before using mcgr.At a minimum follow up of 6 months, after performing 5.7 lengthening procedures per patient (lengthening performed every 60¿90 days), main thoracic scoliosis was corrected from 62.7 degrees to 32.0 degrees (mean correction 49 %), lumbar curve form 58.5 degrees to 32.0 degrees (45 %).The correction was maintained at final follow up.No neurological or infective complications occurred.In one patient a revision was performed due to proximal hooks mobilization.At final follow up, no patient presents pain or functional limitation.This report refers to one patient who had a revision performed due to proximal hooks mobilization.This is report 1 of 1 for (b)(4).This report is for an unknown veptr hook, unknown part#/lot# and unknown quantity.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Greggi (2014): early onset scoliosis (infantile idiopathic scoliosis and magnetically controlled dual growing rod).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: 4599030
• MDR Text Key: 21725069
• Report Number: 2520274-2015-11428
• 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

• Date FDA Received: 03/13/2015
• 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: 02/24/2015
• 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