MAUDE Adverse Event Report: SYNTHES SELZACH NORIAN REINFORCED FAST SET PUTTY/3CC; METHYL METHACRYLATE FOR CRANIPLASTY

Catalog Number CRS-0300-FRP

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient underwent a craniotomy on (b)(6) 2015.The surgeon noted that the 3cc norian reinforced putty has a longer set time than the 10cc.Also, the surgeon mentioned that the strength, intensity, and touch of the 3cc is very different than that of the 10cc.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: patient information is not available for reporting.The actual event date is unknown.It was originally reported as being (b)(6) 2015, but the procedure referenced in the complaint did not occur until (b)(6) 2015.(b)(4).No 510k information is available for this product at this time as it is not currently distributed in the united states.A previously associated 510k number was k102018.The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing site: (b)(4) - manufacturing date: november 11, 2014.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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.

• Brand Name: NORIAN REINFORCED FAST SET PUTTY/3CC
• Type of Device: METHYL METHACRYLATE FOR CRANIPLASTY
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4781078
• MDR Text Key: 5818400
• Report Number: 3000270450-2015-10104
• Device Sequence Number: 1
• Product Code: GXP
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/29/2015

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 Catalogue Number: CRS-0300-FRP
• Device Lot Number: DSC2473
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2015
• Initial Date FDA Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1