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

Device Problem Appropriate Term/Code Not Available (3191)

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: pajulo, o., kyllanen, k., peltonen, j., helenius, i., (2012), complications in patients with veptr instrumentation are strongly associated with basic diagnosis, journal of children's orthopaedics, 6 (suppl 1):s35¿s55.Doi 10.1007/s11832-012-0390-6.The aim of this study was to analyze the results and the complications, related to the diagnosis and the age of the patient.The material consists of 18 patients, eleven boys and seven girls and they received a vertical expandable prosthetic titanium rib (veptr).The age at the time of operation range 1.0¿16.7 years and the follow-up time range 0.6¿5.7 years.The operation indications were congenital scoliosis in eight patients, neuromuscular scoliosis in five, infantile scoliosis in three and one hyperlordosis and one hyperkyphosis patient.There were 22 complications in nine patients, whereas the other nine patients did not have any.The most common complication was loosening of the veptr foundation in 18 cases.Only in two cases was an emergency operation needed and the others were corrected at the next scheduled operation.In four cases there were skin problems and the veptr instrumentation had to be removed in three cases, permanently in two.The author concluded that veptr instrumentation seems to work best in young patients with congenital scoliosis.There is not sufficient information to file multiple reports.Loosening without revision.A copy of the journal article is being submitted with this medwatch.1 of 3 medwatch.

Manufacturer Narrative

Device used for treatment not for diagnosis.Pajulo, o., kyllanen, k., peltonen, j., helenius, i., (2012), complications in patients with veptr instrumentation are strongly associated with basic diagnosis, journal of children's orthopaedics, 6 (suppl 1):s35¿s55.Doi 10.1007/s11832-012-0390-6.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: 3761835
• MDR Text Key: 4417906
• Report Number: 2520274-2014-10915
• 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

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention