CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE 615.10.01S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-14 for CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE 615.10.01S manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[188228369] Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). A device history record (dhr) review was conducted: manufacturing location: supplier - dsm biomedical (b)(4). Expiration date: 28-aug-2017. Part number: 615. 10. 01s, cranios reinforced fast set putty 10cc? Sterile. Lot number: dsd3815 (sterile). Lot quantity: (b)(4). Purchased finished goods traveler met all inspection acceptance criteria. Inspection sheet, incoming final inspection, (b)(4) rev m met all inspection acceptance criteria. Certificate of conformance received from dsm dated 07-may-2016 was reviewed and determined to be conforming. Sterility requirements on certificate were reviewed and determined to be conforming. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition. 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.
Patient Sequence No: 1, Text Type: N, H10


[188228370] It was reported that on (b)(6) 2018, the patient underwent removal of bone cement due to cement fragmentation and infection that was known on (b)(6) 2017. Findings at last follow-up temporal retrusion right, left posterior skull bony contour irregularities. The patient participates in martial arts and notes repeated trauma to the head and, over the past several months, had noted some boggy inflammation in the right forehead region without frank infection. More recently, it developed a small abscess on the upper lid on the right, suggesting some sort of infection of the alloplast, which had presumed to be traumatically fragmented, had chronic inflammation and fragmentation of the phosphate cement both on the right and left temporal regions. It appears that the patient had this with an infection through the right upper lid. The original implant date was on (b)(6) 2016. It is unknown if there was a surgical delay. The procedure and patient outcomes were unknown. This report is for one (1) cranios reinforced fast set putty 10cc-sterile this is report 1 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-00175
MDR Report Key9587247
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-14
Date of Report2019-12-17
Date Mfgr Received2020-01-15
Device Manufacturer Date2016-05-16
Date Added to Maude2020-01-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1MONUMENT
Manufacturer Street1101 SYNTHES AVENUE
Manufacturer CityMONUMENT CO 80132
Manufacturer CountryUS
Manufacturer Postal Code80132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE
Generic NameMETHYL METHACRYLATE FOR CRANIPLASTY
Product CodeGXP
Date Received2020-01-14
Model Number615.10.01S
Catalog Number615.10.01S
Lot NumberDSD3815
Device Expiration Date2017-08-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWRIGHTS LANE SYNTHES USA PRODUCTS LLC
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-14

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