MAUDE Adverse Event Report: SYNTHES USA; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

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

Patient Problems Seroma (2069); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: this report is for an unknown peek implant/unknown lot/quantity unknown.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.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

This report is being filed after subsequent review of the following journal article o¿reilly, e.B., et al (2015).Computed-tomography modeled polyether ether ketone (peek) implants in revision cranioplasty.Journal of plastic, reconstructive and aesthetic surgery.68: 329-338.The authors performed a 6-year retrospective review of cranioplasty procedures using synthes polyether ether ketone (peek) implants.A total of nineteen patients underwent twenty-two cranioplasty procedures.After surgeon approval the final plate was manufactured via synthes.The 19 patients who met inclusion criteria underwent a total of 22 peek cranioplasty procedures from (b)(6) 2006 until (b)(6) 2012.The average age at the primary craniectomy procedure was 39.6 (range 15-81); and 12/19 patients were male.The patients were followed for a minimum of 24 month post-operative (range 24-106 mo, average 59 mo).In three of the nineteen cases the peek implant required removal.The first (patient 7) developed an mrsa post-operative infection one month following peek implant placement; re-utilization of implant 42 months later which was unsuccessful due to inadequate soft tissue coverage and failure to re-expand the dura, leading to infected fluid collection and meningitis.The second case (patient 10) had trauma overlying his cranioplasty site while playing golf, leading to plate exposure and infection.One week post-operatively, the patient developed incisional erythema and a small fluid collection.Prophylactic oral antibiotics were begun for what was eventually found to be a sterile seroma.Months later, the patient lacerated his overlying skin flap while exiting a golf cart, leading to peek implant infection with mrsa and subsequent explantation.Following a fourteen-month quiescent period the patient underwent an uncomplicated peek cranioplasty utilizing the original and unmodified peek plate.The final patient (patient 11) had a occipito-parietal step-off and poor cosmetic outcome, leading to revision of her cranioplasty with utilization of a new peek implant due to bony remodeling in the span between the modeling ct and the initial revision surgery.This case was complicated by postoperative epidural fluid collection and hydrocephalus, treated with a ventriculo-peritoneal shunt.This medwatch refers to patient 10 who one week post-operatively, developed incisional erythema and a small fluid collection.Prophylactic oral antibiotics were begun for what was eventually found to be a sterile seroma.This report is for unknown peek implants.This is report 2 of 3 for complaint (b)(4).

• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6249579
• MDR Text Key: 64765196
• Report Number: 2520274-2017-10139
• Device Sequence Number: 1
• Product Code: GXN
• 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,litera
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• 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: 12/16/2016
• 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: 46 YR