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

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

Patient Problems Fever (1858); Unspecified Infection (1930); Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.The exact date of onset for the patient¿s post-operative infection and fever is unknown.However, the patient¿s fever noticeably began to rise on (b)(6) 2016.This report is for one (1) unknown veptr construct.Without a valid part and lot number, the udi is not available.The original implant procedure was performed on an unknown date in either (b)(6) 2015.The construct was not explanted during the revision on (b)(6) 2016.The procedure was a scheduled extension of the veptr-ii construct.The complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Although there was no reported allegation of malfunction against the device, the surgeon did note that the implant was ¿a bit dirty.¿ investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device used for treatment, not diagnosis.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 (b)(4) reports an event in (b)(6) as follows: it was reported that a patient implanted with a vertical expandable prosthetic titanium rib ii (veptr-ii) developed a post-operative infection requiring medical attention and hospitalization.The patient was originally implanted with a veptr-ii construct on an unknown date in either (b)(6) 2015.Sometime following hospital discharge on (b)(6) 2015, the patient was treated for a urinary tract infection (uti) and suspected post-surgical infection at another hospital.By (b)(6) 2016, the dosage of medication intended to treat the infection had been decreased.However, the patient¿s temperature reportedly began to rise on (b)(6) 2016.The patient was re-admitted to the hospital on (b)(6) 2016 and was started on iv antibiotics for the fever.The patient remained hospitalized through the scheduled veptr-extension procedure, which took place on (b)(6) 2016.The surgeon noted that the distraction lock appeared to be ¿a bit dirty¿ and, therefore, could not be disassociated from the patient¿s fever.A culture was taken, but the results were negative.None of the original hardware was removed during the scheduled revision.This report is for one (1) unknown veptr construct.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Initially it was reported the device was implanted sometime in late (b)(6) 2015 or early (b)(6) 2015; however, it was clarified that the device was implanted initially (b)(6) 2014.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The original implant date was reported to be (b)(6) 2014.

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5820145
• MDR Text Key: 50348200
• Report Number: 2520274-2016-13627
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H030009
• 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,Followup
• Report Date: 07/11/2016

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
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2016
• 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: 6 YR