|
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Event Description
|
This report is being filed after the subsequent review of the following journal article: ¿growth-sparing spinal instrumentation in skeletal dysplasia¿.The purpose of the study is to report the outcomes of distraction-based, growth-sparing spinal instrumentation in patients with skeletal dysplasia.Between 2004 and 2010, 12 children with a diagnosis of various types of skeletal dysplasia underwent growth-sparing spinal instrumentation for severe spinal deformities.Three of the patients were treated with vertical expandable prosthetic titanium rib (veptr).Of the 3 patients, one had a complication of proximal migration of rib cradle, which required revision, and the other 2 patients had anchor dislodgements, which were addressed during planned distraction surgical procedures.This is report 3 of 3 for (b)(4) and is for one unknown veptr construct.¿patient (b)(6) ¿, (b)(6) at the time of surgery, had a complication of screw dislodgement which was addressed during planned distraction surgical procedures.
|
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.The article refers to the patient as patient no.10.Date of event- no date provided.Spine, volume 38, number 24.This report is for 1 unknown veptr construct.Karatas, a.Et al.(2013).Growth-sparing spinal instrumentation in skeletal dysplasia.Spine, volume 38, number 24, pp e1517-e1526.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|