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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2010

Event Type  malfunction  

Event Description

This report is being filed after the subsequent review of the following literature article samy, m.And al zayed, z.(2011).What to expect postoperatively with respect to head tilt in congenital thoracic scoliosis.Eur j orthop surg traumatol (21) 1-5.This study was conducted to evaluate the effect of a vertical expandable prosthetic titanium rib (veptr) on head tilt in patients with congenital scoliosis.Twelve patients with fused ribs, congenital scoliosis (cs), thoracic insufficiency syndrome (tis), and cervical tilt were treated with veptr open wedge thoracostomy.The patients (seven females and five males) had a mean age of 6.5 years (range 5.6¿9.4 years) at the time of surgery.The cobb angles of the primary thoracic curves were measured.Preoperative measurements of cervical tilt angle, first thoracic (t1) oblique take-off angle, head decompensation, and shoulder horizontal angle were all measured.All the patients were treated with veptr open wedge thoracostomy.All patients had combinations of congenital vertebral abnormalities and chest wall anomalies, including unilateral unsegmented vertebral bars, hemivertebrae, butterfly vertebrae, and fused ribs of the concave hemithorax.All patients underwent a standard open wedge veptr thoracostomy.A rib to spine veptr construct was applied in eight patients, and double constructs (rib to rib and rib to spine) were applied in four patients.One patient had migration of the veptr device through the bone at the superior cradle and was treated at the time of an elective lengthening by reinsertion at the original anchor site where bone had reformed.There were problems with pedicle screws in one patient, who had radiological loosening and position change.No neurological problems (brachial plexus, intercostals nerves, spinal cord) had been reported in any of our patients.There was statistically significant improvement in thoracic cobb angle.At the end of follow-up there was significant improvement in the shoulder horizontal angle from 14.4° to 6.7°.Head decompensation had improved to = 2 cm in nine patients.Both thoracic oblique take-off angle and cervical tilt angle had improved from 35.1° to 33.9° preoperatively to 30° and 27.2° at the end of follow-up.This is 2 of 2 for com-(b)(4).This report is regarding 2 veptr devices.A copy of the literature article is being submitted with this medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Samy, m.And al zayed, z.(2011).What to expect postoperatively with respect to head tilt in congenital thoracic scoliosis.Eur j orthop surg traumatol (21) 1-5.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.

• 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: 4579963
• MDR Text Key: 5448805
• Report Number: 2520274-2015-11506
• 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?: No
• 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: 03/09/2015
• 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