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

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

Patient Problems Pain (1994); Impaired Healing (2378)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: waldhausen, j.H.T., redding, g.J., and song, k.M.(2007).Vertical expandable prosthetic titanium rib for thoracic insufficiency syndrome ¿ a new method to treat an old problem.Journal of pediatric surgery vol 42, p76-80.Usa article.This was retrospective review of performed between (b)(6) 2001 and (b)(6) 2005.The study population included: 22 patients, 36 veptr devices, most had undergone sequential veptr expansions, age range 1 year and 8 months ¿ 15 years and 3 months.Twenty seven devices were hybrid and 9 were radial constructs.Patients had between 1-3 veptr devices placed.Complications included: veptr erosion through bone or dislodgment (n=7) which required revision surgery (most at the superior grade of hybrid device; 3 patients had implants removed.Outgrown (n=5) and were replaced or removed.Soft tissue erosion/eschar (n=1) causing superficial infection that was debrided and resolved with a revision.Carbon dioxide reduction post-veptr (n=2), post-op seroma (n=1), average age 8.38 years had worse ventilation on the affected side, avg age 6.64 years had worse perfusion post-op, worse respiratory function (n=2) needing increased respiratory support and progression to non-invasive ventilation.On (b)(6) 2015, update: k-wires utilized during veptr surgery as intramedullary pins which were placed into ribs to recreate the horizontal portion of the rib and tie it to the veptr.Surgeon stated, "i had to remove one of the wires in one patient due to pain at the site which resolved after removal.There have been no other issues." k-wires part of veptr set per surgeon.This report refers to removal of k-wire in one patient due to pain.This is report 4 of 4 for (b)(4).This report is for an unknown veptr with an unknown part number, lot number and quantity.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: (b)(4).This report is for an unknown veptr k-wire with unknown part and lot numbers.(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; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4746421
• MDR Text Key: 21935859
• Report Number: 2520274-2015-13448
• 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: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• 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: 04/13/2015
• 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