MAUDE Adverse Event Report: SYNTHES MONUMENT CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE; METHYL METHACRYLATE FOR CRANIPLASTY

Catalog Number 615.05.01S

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Cerebrospinal Fluid Leakage (1772); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient¿s date of birth and weight are not available for reporting.The date the cement popped out is unknown.(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4).A device history record (dhr) review was performed on part# 615.05.01s lot# dsd3819: release to warehouse date: 25-may-2016, expiration date: 28-aug-2017, supplier: dsm biomedical-kensey nash: no non conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported that a cranioplasty for a cranial defect occurred on (b)(6) 2017 and it was discovered that the cranios bone cement popped out in one piece postoperatively following the cranioplasty.Prior to placing the cement, the surgeon needed to remove some necrotic brain tissue.After placement of the cement, the cement cured successfully.Twenty-four hours postoperatively, the patient developed a cerebrospinal fluid (csf) leak which increased the intracranial pressure (icp) in the skull.When the surgeon went back in to fix the csf leak, it was discovered that the cement had popped out in one piece.There was no patient harm.The sales consultant stated that it takes 48 hours for the cement to cure and the cement was not fully cured at that point.The surgeon felt the issue was due to the csf leak and not due the cranios cement.The surgeon repaired the leak, removed the cement and reconstructed with a synthes titanium mesh on (b)(6) 2017.The patient outcome was reported as fine.This report is for one (1) cranios reinforced fast set putty 5cc-sterile.This is report 2 of 2 for complaint com-(b)(4).

• Brand Name: CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE
• Type of Device: METHYL METHACRYLATE FOR CRANIPLASTY
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6568680
• MDR Text Key: 75264569
• Report Number: 1719045-2017-10469
• Device Sequence Number: 1
• Product Code: GXP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Catalogue Number: 615.05.01S
• Device Lot Number: DSD3819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR