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

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 11/05/2014

Event Type  Injury  

Event Description

This report is being filed after subsequent review of the following abstract: karlin and et al: management of thoracic insufficiency syndrome in patients with jarcho-levin syndrome using veptrs (vertical expandable prosthetic titanium ribs).The journal of bone & joint surgery, volume 96-a, number 21, e181(1-8).Twenty nine patients with jarcho-levin syndrome, subclassified as spondylocostal dysostosis (scd) or spondylothoracic dysplasia (std), were treated with veptr expansion thoracoplasty and followed for at least two years since the initial implantation.The 10 of the 29 patients, 3 females and 7 males; mean age 3.1 years, were diagnosed with scd.19 of the 29 patients, 14 females and 5 males; mean age 4.1, were diagnosed with std.During the study period, 19 cases of device migration, 2 cases of hooks fracturing, 2 cases of wound dehiscence, 2 cases of deep infections, 4 cases of superficial infections, and 1 case of a natural rib fracture.In total, the complications required only twelve additional, unplanned surgical sessions, representing 3% of all surgical sessions.Patients with scd displayed increased lumbar lordosis, and both groups of patients developed increased thoracic kyphosis approaching normal.This report refers to one fractured hook post-operatively.The hook was repaired during an unscheduled surgery.This is report 5 of 5 for (b)(4).This report is for an unknown veptr construct, unknown part#/lot#.

Manufacturer Narrative

(b)(4).This report is for unknown veptr hook/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: 4580090
• MDR Text Key: 5339762
• Report Number: 2520274-2015-11507
• 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: 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: 03/09/2015
• 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