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

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

Patient Problems Tissue Damage (2104); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following article: the treatment of secondary thoracic insufficiency syndrome of myelomeningocele by a hybrid veptr ¿¿eiffel tower¿¿ construct with s-hook iliac crest pedestal fixation.Campbell, r., et al (2007).Journal 14: 287-293.This study evaluated the use of a hybrid veptr ¿¿eiffel tower¿¿ construct with s-hook iliac crest pedestal fixation as treatment for patients with secondary thoracic insufficiency syndrome due to myelomeningocele.Ten patients were enrolled in the study.The average follow-up was 5.75 years (2¿11.5 years) patients were separated into 2 groups: unilateral hybrids (8 pts.) and bilateral (2 pts.).Six patients had a marionette sign preoperatively, none at follow-up.The ratio of diaphragm depth/abdominal height improved from 2.17, preoperatively to 1.56 at follow-up.Lumbar kyphosis improved from 43° to 26°.Thoracic/lumbar spine height increased 5.8 mm/year.Pelvic obliquity improved from 34° to 11°.Coronal moment arm of iliac crest shook fixation was 2.4 times longer than a theoretical pedicle screw at the same level.Asymptomatic hook migration through average 39 mm ¿¿safe zone¿¿ of iliac crest was 24 mm (6.3 mm/year, or 16% ¿¿safe zone¿¿/year) unilateral hooks migrated at 8.4 mm/year, bilateral at 7.4 mm/year.No slow migrations required reseating.One s-hook incorrectly placed but did require acute reseating.Scoliosis improved from 73° to 46°.Complications include: 3 s-hook fractures, 2 rib cradle migrations, 1 skin slough, and 4 wound infections.One patient died of respiratory failure unrelated to surgery.The authors concluded that the veptr expansion thoracoplasty with a hybrid veptr ¿¿eiffel tower¿¿ construct with s-hook iliac crest pedestal fixation is a powerful means to correct pelvic obliquity because of inherent biomechanical advantage of an extended lateral moment arm compared to central spinal fixation, and spine infection appears be avoided because the central skin scarring in myelomeningocele is not violated.This is report 1 of 1 for (b)(4).This report is for unknown veptr.

Manufacturer Narrative

Device used for treatment, not diagnosis.The treatment of secondary thoracic insufficiency syndrome of myelomeningocele by a hybrid veptr ¿¿eiffel tower¿¿ construct with s-hook iliac crest pedestal fixation.Campbell, r., et al (2007).Journal 14: 287-293.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.

• 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: 4592180
• MDR Text Key: 5481674
• Report Number: 2520274-2015-11671
• 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

• Date FDA Received: 03/11/2015
• 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: 02/15/2015
• 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