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 Cerebrospinal Fluid Leakage (1772)

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: henry l., et al (2019) evaluation of csf leak rate in acoustic neuroma resection and techniques of internal auditory canal reconstruction, journal of neurological surgery b skull base, volume 80 (s 01) , pages s1- s244 (usa).This retrospective study aims to evaluate the incidence of cerebrospinal fluid (csf) leak following acoustic neuroma resection.To compare csf leak rates based on the various techniques for reconstruction of the internal auditory canal (iac).From 2005 to 2018, a total of 263 patients with acoustic neuromas who underwent surgical resection for management of their lesion were analyzed.Retrosigmoid and translabyrinthine approaches to acoustic neuroma resections were performed with bone wax and muscle plug or norian hydroxyapatite bone cement from 2005 to 2013.Starting in 2014, a newer model of bone cement, cranios hydroxyapatite, was used for reconstruction.The following complications were reported as follows: twelve of the 263 patients analyzed experienced a postoperative csf leak.5 leaks occurred with norian hydroxyapatite bone cement.1 leak occurred with cranios hydroxyapatite bone cement.Cranios had a significantly reduced rate of postoperative csf leak.This report is for an unknown synthes norian hydroxyapatite bone cement and unknown cranios hydroxyapatite.This report involves one (1) unknown biomaterial - cement: cranios reinforced: trauma.This is report 2 of 2 for (b)(4).

• 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: 10128371
• MDR Text Key: 194354541
• Report Number: 2939274-2020-02697
• 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: Physician
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2020
• 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