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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This report is being filed after subsequent review of the following abstract: smith: treatment of progressive spinal deformity using the vertical expandable prosthesis titanium rib (veptr) device with a bilateral percutaneous rib to pelvis technique in non-ambulatory children with neuromuscular disease.The 2nd international congress on early onset scoliosis and growing spine, november 7¿8, 2008.Pg 162.Usa.This article retrospectively reviewed 11 children with progressive scoliosis or kyphosis associated with neuromuscular disease treated with the bilateral percutaneous rib to pelvis technique.The diagnosis was varied (spina bifida 5; myopathy/spinal muscular atrophy (sma) 3; cerebral palsy 1; unclassified syndromes 2) all were non-ambulators and wheelchair dependent.Eight patients had scoliosis, 2 had kyphosis, and one had lordosis.The average age at the time of index surgery was 76 months (range 22¿131 mo) and the average length of follow up was 24.3 months.For the scoliosis group, there was improvement in the average pre-op coronal cobb angle from 65 degrees to 47 degrees.The sagittal cobb angle improved from 53 to 31 degrees.For the sagittal deformity group (3), the average pre-op sagittal cobb was 116 degrees and improved to 64 degrees at an average follow-up of 32 months.Adverse events were uncommon and easily managed (pelvic migration 1, rib cradle migration 8 in 4 patients, wound dehiscence 5 in 2 patients).This report refers to complications reported pelvic migration 1, rib cradle migration 8 in 4 patients, wound dehiscence 5 in 2 patients.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.Smith: treatment of progressive spinal deformity using the veptr device with a bilateral percutaneous rib to pelvis technique in non-ambulatory children with neuromuscular disease.The 2nd international congress on early onset scoliosis and growing spine, november 7¿8, 2008.Pg 162.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 this reports to the following complications: pelvic migration 1, rib cradle migration 8 in 4 patients.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: 4577823
• MDR Text Key: 5550015
• Report Number: 2520274-2015-11378
• 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: 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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 03/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2015
• 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