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U.S. Department of Health and Human Services

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

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SYNTHES USA; PROSTHESIS, RIB REPLACEMENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pulmonary Insufficiency (2022)
Event Type  Injury  
Event Description
This report is being filed after the subsequent review of the following literature article; (2009)" early changes in pulmonary function after (veptr) vertical expandable prosthetic titanium rib insertion in children with thoracic insufficiency syndrome" mayer; j.Pediatr orthop; volume 29, number 1, january/february 2009.This article reports that the vertical expandable prosthetic titanium rib (veptr) has been inserted in children with thoracic insufficient syndrome (tis) for the last decade to expand and support the chest and allow for further lung growth.The results conclude that on the 53 subjects a formal analysis was performed.Results indicated that 85% of these subjects were observed to have decrease in forced vital capacity (fvc) and forced expired volume in one second (fev1)%.Only 15% of children had improved fvc after veptr insertion, only one of which was an increase into the normal range.There was a statistically significant increase in residual volume (rv), but the increase in rv% did not reach statistical significance.There was a significant increase in residual volume (rv) over total lung capacity (tlc) after veptr insertion.The conclusion stated that although there is clinically and radiographically apparent expansion of the thorax after veptr insertion, there is no similar improvement in lung volume, and instead there is a decrease in forced vital capacity and increase in residual volume.This is report 1 of 1 for (b)(4).This report is for an unknown veptr, unknown part/unknown lot/ unknown quantity.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.This report is for unknown veptr, unknown quantity, unknown item number and unknown lot number.(b)(6).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.
 
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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 Key4571932
MDR Text Key5475476
Report Number2520274-2015-11448
Device Sequence Number1
Product Code MDI
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
PH030009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type 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
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
Initial Date Manufacturer Received 02/15/2015
Initial Date FDA Received03/05/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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