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

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); Pneumonia (2011); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis the veptr ¿¿parasol¿¿ expansion thoracoplasty for treatment of transverse volume depletion deformity of the convex hemithorax rib hump in early onset scoliosis.Campbell, r., et al (2007).J child orthop 1: 255-276.This report is for an 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 were provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following article: the veptr ¿¿parasol¿¿ expansion thoracoplasty for treatment of transverse volume depletion deformity of the convex hemithorax rib hump in early onset scoliosis.Campbell, r., et al (2007).J child orthop 1: 255-276.This study evaluated the use of the use of the veptr ¿¿parasol¿¿ expansion thoracoplasty for treatment of transverse volume depletion deformity of the convex hemithorax rib hump in children with early onset scoliosis.Ten patients were evaluated.They had an average follow-up of 6 years from initial concave surgery and 4 years from convex parasol procedure.Seven patients had 70 mm radius veptr, 4 patients had hybrid/rib-rib veptr.Cobb angle pre-op 79°, pre-convex proc 51°, 49° at follow-up.Space available for lung (sal) 1.5 pre-op, 0.92 at follow-up.Concave/convex hemithorax width ratio was 2.79 pre-concave implant, 3.07 pre-convex implant, and 2.17 follow-up.Ct lung volumes (n = 6): pre-implant convex/concave lung volume ratio was 0.87, 0.91 at follow-up.Average vital capacity at follow-up was 37.8% predicted (n = 9).Patient complications include: (4) spinal hook migration, (3) superior migration rib cradles, (1) fractured hybrid, (1) titanium sling migration, (3) infection, (3) skin slough, (2) pneumonia.Expansion of the rib hump in early onset scoliosis by the veptr ¿¿parasol¿¿ procedure increases the lateral width of the hemithorax on radiograph.Some improvement in the convex/concave lung volume ratio is seen.Scoliosis is not increased by the convex distraction.The complication rate is frequent, but treatable.Significance the loss of transverse volume in the convex hemithorax due to rib hump of the patient with early onset scoliosis contributes to thoracic insufficiency syndrome.The veptr ¿¿parasol¿¿ expansion thoracoplasty directly addresses the anatomic deformity of rib hump, probably partially reversing the convex volume depletion problem.If done early in life, this may help encourage convex lung growth.For any growing patient with rib hump, especially if vital capacity is low, the ¿¿parasol¿¿ procedure should be considered instead of a traditional orthopaedic thoracoplasty.This is report 1 of 1 for (b)(4).This report is for unidentified patients for an unknown veptr.

• 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: 4592121
• MDR Text Key: 22226398
• Report Number: 2520274-2015-11678
• 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