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

Catalog Number UNK - VEPTR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date the abstract was published is unknown.This report is for unknown veptr, unknown part/unkown lot.This report for 5 unknown veptr.Implant, explant dates: unknown without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4), comparison of surgical treatments for infantile and juvenile scoliosis, pg# 72 abstract# 30 scoliosis research society, 47th annual meeting & course, sep 5-8, 2012.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following journal article: "scoliosis research society 47th annual meeting and course final program, abstract# 30: joshua m.Pahys et al: comparison of surgical treatments for infantile and juvenile scoliosis.A retrospective review of 31 patients evaluated vertical expandable prosthetic titanium rib (veptr) vs.Growing rods (gr) for the treatment of infantile/juvenile scoliosis.18 patients of the 31 were treated with the vertical expandable prosthetic titanium rib and the rest of the 13 patients were treated with growing rods.There was no difference between the two groups (age at initial surgery, sex, diagnosis, height/weight, and preop coronal/ sagittal cobb angle).Average follow-up for vertical expandable prosthetic titanium rib was 4.2 years vs growing rods 3.5 years.Among the 18 patients that were treated with vertical expandable prosthetic titanium rib; complications occured in 8, instrument migration/failure in 12 patients and wound infection in 5 patients.This is report 2 of 4 for (b)(4).This report for unknown veptr, implanted in 5 patients.

• 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: 3765508
• MDR Text Key: 21169079
• Report Number: 2520274-2014-10989
• 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: Other
• Type of Report: Initial
• Report Date: 04/03/2014

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
• Device Catalogue Number: UNK - VEPTR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 04/22/2014
• 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