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

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

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 (b)(4)) constructs for thoracic insufficiency syndrome between 2001 and 2007.A 73 month old female with neuromuscular scoliosis underwent implantation of veptr for the treatment of rib fractures.Subsequently, the rods fractured at the third expansion; and subsequent rod fracture after fifth expansion.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.¿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.This report is for an unknown veptr construct/unknown lot.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: 3760366
• MDR Text Key: 4465005
• Report Number: 2520274-2014-10905
• 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: 04/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 73 MO