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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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 2 of 3 for (b)(4) and is for one unknown veptr construct.¿patient no.10¿, a female, who was (b)(6) months old at the time of surgery, had a complication of proximal migration of rib cradle through ribs 2 and 3 which required an unplanned revision.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Pt identifier: 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.

• Type of Device: PROSTHESIS, 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: 3776174
• MDR Text Key: 4374270
• Report Number: 2520274-2014-11039
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2014

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 04/28/2014
• 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
• Patient Age: 98 MO