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

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

Patient Problem No Code Available (3191)

Event Date 07/14/2016

Event Type  Injury  

Manufacturer Narrative

Patient id, dob & weight not provided for reporting.Udi: unknown part number, unknown lot number, udi is unavailable.This report is for unknown unk - veptr/unknown lot number.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).It was reported that the patient developed proximal junctional kyphosis which required revision surgery to remove hardware.Without a lot number, the device history record review and 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.

Event Description

Device report from synthes on an event in device report from synthes on an event in (b)(6) as follows: it was reported that on (b)(6) 2011 an initial surgery was on a (b)(6) male patient for left side of t5-l4 and (size 9) vertical expandable prosthetic titanium rib (veptr) and right side of t5-l4 and size is (size 10) veptrii.On (b)(6) 2012 replacement surgery was performed left side of veptr (6 extension).On (b)(6) 2015, replacement surgery was performed right side of veptrii (2 extension).In (b)(6) 2015, the patient had proximal junctional kyphosis.On (b)(6) 2016 the surgeon performed the last fixation to t2-l1 and removed both right and left of hybrid type.According to the surgeon couldn't identify the cause veptr or veptrii.On (b)(6) 2016 (date of event) the patient had proximal junctional kyphosis.Complaint involves 2 parts.This report is 1 of 2 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: 6074658
• MDR Text Key: 59010519
• Report Number: 2520274-2016-15180
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2016

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: 10/12/2016
• Initial Date FDA Received: 11/02/2016
• 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
• Patient Age: 13 YR