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

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

Patient Problems Adult Respiratory Distress Syndrome (1696); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Type  Injury  

Event Description

This report is being filed after subsequent review of the following article: campbell (2004): the effect of opening wedge thoracostomy on thoracic insufficiency syndrome associated with fused ribs and congenital scoliosis.The journal of bone & joint surgery, vol 86-a.Number 8, pg 1659-1674.Twenty-seven patients with congenital scoliosis associated with fused ribs of the concave hemithorax had an opening wedge thoracostomy with primary longitudinal lengthening with use of a chest-wall distractor known as a vertical, expandable prosthetic titanium rib (veptr).Repeat lengthenings of the prosthesis were performed at intervals of four to six months.Radiographs were analyzed with respect to correction of the spinal deformity, as indicated by a change in the cobb angle, and lateral deviation of the spine, as indicated by the inter-pedicular line ratio.Spinal growth was assessed by measuring the change in the length of the spine.Correction of the thoracic deformity and thoracic growth were assessed on the basis of the increase in the height of the concave hemithorax compared with the height of the convex hemithorax (the space available for the lung), the increase in the thoracic spinal height, and the increase in the thoracic depth and width.The thoracic deformity in the transverse plane was measured with computed tomography, and the scans were analyzed for spinal rotation, thoracic rotation, and the posterior hemithoracic symmetry ratio.Clinically, the patients were assessed on the basis of the relative heights of the shoulders and of head and thorax compensation.Pulmonary status was evaluated on the basis of the respiratory rate, capillary blood gas levels, and pulmonary function studies.This report refers to complications reported post-operatively: ; four patients had skin slough, two patients had one infection at the site of the device, and one patient had two infections; all four infections were associated with skin slough, and débridement and antibiotics were used for treatment.Three patients had mild low-back pain, which resolved promptly after expansion of the hybrid device in two of them.The third patient had symptomatic upper lumbar junctional congenital kyphosis, which responded to a pedicle subtraction osteotomy.The pediatric form of adult respiratory distress syndrome developed after the surgery in two patients and required prolonged ventilator support before resolving without sequelae.Upper-extremity brachioplexopathy developed in two patients after the surgery.Both cases seemed to be related to malposition of the hybrid rib prosthesis, and both resolved after repositioning.This is report 3 of 5 for (b)(4).This report is for an unknown veptr construct, unknown part#/lot#.A copy of the literature abstract is being submitted with this medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Campbell (2004): the effect of opening wedge thoracostomy on thoracic insufficiency syndrome associated with fused ribs and congenital scoliosis.The journal of bone & joint surgery, vol 86-a.Number 8, pg 1659-1674.This report is for unknown veptr/unknown quantity/unknown lot.Initial reporter phone number: (b)(6).(b)(4).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 REPLACEMET
• 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: 4605354
• MDR Text Key: 5629161
• Report Number: 2520274-2015-11384
• 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: 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

• Date FDA Received: 03/16/2015
• 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: 02/15/2015
• 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