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

Catalog Number 615.05.01S

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Due to intra-operative issues, the device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, as the device was reportedly discarded by the facility.Part 615.05.01s, lot dsd5873: release to warehouse date: august 15, 2016.Expiration date: september 28, 2017.Supplier: (b)(4).No non-conformance reports were generated during production.Review of device history records 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 the patient underwent surgery for a cranial defect repair on (b)(6) 2017 and during the procedure the bone cement (cranios) hardened but did not adhere to the bone.The cranios biomaterial was removed and a non-synthes product was being implanted to complete the procedure.As a result of these events there was a surgical delay of an unspecified length.The patient outcome was reported as stable.It was reported that the cranios had been stored at room temperature and the expiration date was september 28, 2017.Information was not provided on the time sequence for mixing, implantation and setting of the bone cement.This is report 1 of 1 for (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: 6299797
• MDR Text Key: 66769109
• Report Number: 1719045-2017-10081
• 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: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Catalogue Number: 615.05.01S
• Device Lot Number: DSD5873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1