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

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

Patient Problem Joint Swelling (2356)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article.Proximal junctional kyphosis after vertical expandable prosthetic titanium rib insertion.Ying li, md, meryl gold, ba, lawrence karlin, md.Spine deformity 1 (2013) 425-433.The literature article is attached to the complaint.This is a retrospective review of patients who had undergone vertical expandable prosthetic titanium rib (veptr) treatment at a single institution.A total of 68 patients underwent veptr treatment between 1999 and 2009.Diagnosis, age at time of veptr insertion, location of veptr anchors, preoperative and postoperative scoliosis, t2-t12 kyphosis and proximal junctional kyphosis (pjk), time from veptr insertion to development of pjk, revision procedure for significant pjk, change in pjk after the revision procedure, and pjk at final follow-up were recorded.Four patients developed pjk (6 percent).One patient had congenital scoliosis with rib fusions, 1 had scoliosis associated with a syndrome (arthrogryposis), and 2 had neuromuscular scoliosis (core myopathy and spinal cord tumor).Mean follow-up was 5.7 years.All patients developed pjk within the first year after veptr insertion.Two patients underwent revision to growing rods.One of these patients had preoperative halo-gravity traction.Mean pjk in these 2 patients improved after revision and remained stable at an average follow-up of 2.9 years.This report is for unknown veptr construct.This is report 2 of 5 for (b)(4), for (b)(6).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Proximal junctional kyphosis after vertical expandable prosthetic titanium rib insertion.Ying li, md, meryl gold, ba, lawrence karlin, md.Spine deformity 1 (2013) 425-433.This report is for unknown veptr construct.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: COMMON NAME 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: 3770627
• MDR Text Key: 17952275
• Report Number: 2520274-2014-11037
• 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 Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2014
• 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