MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - BIOMATERIAL - CEMENT: CRANIOS REINFORCED: TRAUMA; METHYL METHACRYLATE FOR CRANIPLASTY

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown biomaterial - cement: cranios reinforced: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: shakir, s.Et al (2020), a comparison between autologous bone graft and carbonated calcium phosphate cement for secondary cranioplasty; a long-term institutional experience, cleft palate-craniofacial journal, conference: 77th annual meeting of the american cleft palate-craniofacial association, vol.57 (4 supplement), page 1 (usa).The aim of this retrospective cohort study is to compare the authors' long-term institutional experience using cranios and autologous bone grafting for secondary cranioplasty refinements in pediatric and adult patients.Between june 2007 to august 2018, a total of 159 patients underwent secondary cranioplasty for forehead reshaping.Surgery was performed using cranios, a carbonated calcium phosphate (ccp) bone cement in 112 patients, with a mean age of 15.5 years.While 47 patients, with a mean age of 14 years, uses an autologous bone graft (abg).The follow-up period was unknown.The following complications were reported as follows: complications rates in the ccp cohorts was 11.8%.Majority of the complications was related to infection.Factors associated with complications in the ccp cohort included clean-contaminated wound class (p <.001) and proximity to the frontal sinus (p <.03).This report is for an unknown synthes cranios cement.This is report 1 of 1 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - BIOMATERIAL - CEMENT: CRANIOS REINFORCED: TRAUMA
• Type of Device: METHYL METHACRYLATE FOR CRANIPLASTY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10122606
• MDR Text Key: 194119358
• Report Number: 2939274-2020-02677
• Device Sequence Number: 1
• Product Code: GXP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention