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: vilalta vidal, i., (2011), scoliosis in imperfect osteogenesis: is veptr a treatment option?, european spine journal, 20:2067¿2095.Doi 10.1007/s00586-011-2013-1.Imperfect osteogenesis is an osteochondrodysplasia caused by a mutation of the type i collagen gene.Clinically, it is manifested by multiple fractures that produce shortening, with deformities and scoliosis.In this abstract patients were treated with a vertical expandable prosthetic titanium rib (veptr) product.There were three cases presented, two girls and one boy their ages is nine, six, and four years at surgery with severe scoliosis.Follow-up was performed 18 months to six years.Complications included pull-out due rib fracture in two patients, both occurring after the first lengthening and requiring a reoperation with new fixation.There is not sufficient information to file multiple reports.A copy of the journal article is being submitted with this medwatch.

Manufacturer Narrative

Device used for treatment not for diagnosis.Vilalta vidal, i., (2011), scoliosis in imperfect osteogenesis: is veptr a treatment option?, european spine journal, 20:2067¿2095.Doi 10.1007/s00586-011-2013-1.This report is for an unknown veptr.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: 3761784
• MDR Text Key: 4482544
• Report Number: 2520274-2014-10921
• 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: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2014

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: Other
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2014
• Initial Date FDA Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention