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

Device Problem Failure to Osseointegrate (1863)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following article:veptr in non-ambulatory myelodysplasia patients.Flynn, r., et al (2007).J child orthop (2007)1: 255-276.The purpose of this report is to evaluate the patients with spina bifida and spinal deformity treated with the vertical expandable prosthetic titanium rib (veptr) and included in the fda request for approval of humanitarian device exemption for the vertical expandable prosthetic titanium rib.The fda report includes 247 patients with surgeries performed by members of the chest wall deformity study group.Twenty patients were myelodysplastic none ambulatory.Data from remaining 16 patients with adequate follow up was extracted from the fda report and analyzed.The average age at the first surgery was 5 years; average follow up was 47.3 months.In nine patients the cobb angle was decreased an average of 14.4°; in five patients increased 12.6°.Thoracic spinal height was increased in twelve patients an average of 3.2 cm.And lost in two patients 0.8 cm.Twelve patients improved and two patients deteriorated ventilatory function.Implant lengthening was done on the average of every sixth months and device exchange every 30 months.Complications in five patients were due to the severity of the decreased pulmonary capacity.Implant failure and skin breakdown occurred in six patients.The rate of complications reported in this group of patients lies within the range reported for spinal fusion using standard approaches.The number of surgical procedures increases due to the need for expanding the implants as the child grows.The advantages of the veptr are: surgical incisions are away from the midline avoiding the midline scarred tissue and allowing growth of the spinal column with improved space available for the lung.This is report 1 of 1 for (b)(4).This report is for unidentified patients for an unknown veptr.

Manufacturer Narrative

Device used for treatment, not diagnosis veptr in non-ambulatory myelodysplasia patients.Flynn, r., et al (2007).J child orthop (2007)1: 255-276.This report is for an unknown veptr/unknown quantity/unknown lot.(b)(6).No patient codes available for worsening cobb angle, decreased thoracic spinal height, decreased pulmonary capacity, deteriorated ventilatory function the investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number were 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: PROTHESIS, 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: 4592224
• MDR Text Key: 5466395
• Report Number: 2520274-2015-11676
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Physician
• Type of Report: Initial
• 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: 02/15/2015
• Initial Date FDA Received: 03/11/2015
• 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