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

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment not diagnosis.Waldhausen, j., redding, g., white, k., song, k.(2016) complications in using the vertical expandable prosthetic titanium rib (veptr) in children.Journal of pediatric surgery, vol.51, pp: 1747-1750.This report is for unknown vertical expandable prosthetic titanium rib (veptr) system.(other number) udi: unknown part number, udi is unavailable.Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were provided.(b)(4).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 journal article: waldhausen, j., redding, g., white, k., song, k.(2016) complications in using the vertical expandable prosthetic titanium rib (veptr) in children.Journal of pediatric surgery, vol.51, pp: 1747-1750.This report describes complications using the vertical expandable prosthetic titanium rib (veptr, depuy synthes, (b)(4)) for thoracic insufficiency syndrome (tis).Thirty-five (35) patients with veptr i implants and 30 patients with veptr ii implants were included in this study between october 2001 and november 2014.The average age at implantation was 6.9 years (range 1.3¿24.8 years) with an average follow up of 6.9 years (range 0.4¿14.8 years).Twelve children (18.5%) had migration of either the superior cradle hook or the inferior fixation.One of these children (1.5%) had failure of the spinal fixation screws.Two children (3.1%) had migration of the sacral s hook into the pelvis.The other 9 had migration of the superior cradle (13.8%).All of these children either required veptr revision or were at a point in treatment that they underwent veptr removal and final spinal fusion.Three patients had implant fracture, 1 from the veptr itself and 2 from the intramedullary wire placement (4.6%) used in our early patients to provide extra rigidity to the chest wall.Three of the 11 patients who underwent chest wall reconstruction developed persistent pain, 1 from a broken intramedullary wire, 1 from the veptr rubbing on the native rib and 1 from a titanium rib fracture plate dislodging from a rib.This report is for an unknown vertical expandable prosthetic titanium rib (veptr) system.This is report 1 of 3 for (b)(4).

• Type of Device: PROSTHESIS, RIB REPLACEMENT LAMINATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6245166
• MDR Text Key: 64597067
• Report Number: 2520274-2017-10120
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2017

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?: No
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/12/2017
• 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