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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Lattig, f., et al.(2016) treatment of early-onset spinal deformity (eosd) with veptr.Clin spine surg; 29:e246-e251.This report is for unknown veptr, unknown quantity, unknown lot.Other number: udi: unknown part number, udi is unavailable.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received: this report is being filed after the subsequent review of the following literature article: lattig, f., et al.(2016) treatment of early-onset spinal deformity (eosd) with veptr.Clin spine surg; 29:e246-e251.X-rays of 5 children treated for early-onset spinal deformity (eosd) with 2 unilateral vertical expandable prosthetic titanium rib (veptr) were analyzed for curve patterns and cobb angles before, during, and at the end of veptr treatment, and after the final spondylodesis.All patients showed a marked decompensation of the frontal balance.Five patients were included in the study.This report is for an unknown veptr system and refers to the following: patient 4, female, date of birth: (b)(6) 1998, posterior dislocation of the nucleus pulposus at the level of the laminar hook, requiring definitive correction spondylodesis, patient showed progressive loss of head control and a progressive lateral shift of her trunk, which seemed to be caused by the direction of the veptr distraction this is report 4 of 5 for (b)(4).

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5956960
• MDR Text Key: 54957651
• Report Number: 2520274-2016-14559
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• 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