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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article ¿veptr growing rods for early-onset neuromuscular scoliosis.¿ daines, b.K., md, frost, n., md, song, k.M., md, white, k.K., md (2011, january, 7).Clinical orthopaedic related research, 469, 1335-1341.Fifty patients were treated with the vertical expandable prosthetic titanium rib (veptr; synthes north america, west chester, pa) constructs for thoracic insufficiency syndrome between 2001 and 2007.A (b)(6) female with neuromuscular scoliosis underwent implantation of veptr for rib fractures, and progression of curve.Subsequently, the patient experienced recurrent superficial infections, dehiscence, advancement flap; and subsequently had the left rod removed.It was concluded that this study suggests growing constructs using veptrtm can be used with relatively few complications and extends the potential uses of this instrumentation system.This is report 1 of 1 for (b)(4).This report is for an unknown veptr construct.This report is for 1 device.

Manufacturer Narrative

Device for treatment, not diagnosis.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.(b)(4).

• 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: 3760079
• MDR Text Key: 4485690
• Report Number: 2520274-2014-10904
• 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: 04/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2014
• 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
• Patient Age: 47 MO