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

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

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: ersahin, y, turhan, t.(2011).39th annual meeting of the international society for pediatric neurosurgery: abstract ¿ the vertical expandable prosthetic titanium rib (veptr) in the treatment of spinal deformity in growing children.Childs nervous system vol 27, p1781.This was ¿retrospective¿ review of patients who had veptr implants performed on unknown dates.Turkey article.The study population included 9 patients (5 boys, 4 girls), age range 4-12 (mean 7.3yrs).Expansion done every 6 months.Some had spinal cord release before veptr surgery.Complications: construct removed in one patient due to skin breakdown.This is report 1 of 1 for (b)(4).This report is for an unknown veptr with unknown part and lot number and unknown quantity.A copy of the literature article (or abstract) is being submitted with this medwatch.This report is for 1 device(s).

Manufacturer Narrative

Literature citation: ersahin, y, turhan, t.(2011).39th annual meeting of the international society for pediatric neurosurgery: abstract ¿ the vertical expandable prosthetic titanium rib (veptr) in the treatment of spinal deformity in growing children.Childs nervous system vol 27, p1781.This report is for an unknown quantity of veptr with unknown part and lot numbers.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.(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: 4592306
• MDR Text Key: 16883880
• Report Number: 2520274-2015-11704
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Physician
• Type of Report: Initial
• Report Date: 02/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• 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?: Yes
• Date Manufacturer Received: 02/15/2015
• 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