TI MATRIXNEURO SCREW SELF-DRILLING 4MM 04.503.104.01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-10 for TI MATRIXNEURO SCREW SELF-DRILLING 4MM 04.503.104.01 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[113569214] Additional product codes: jey, gxr. Date of explant reported as one month after implant, exact date is not known. 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. 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.
Patient Sequence No: 1, Text Type: N, H10


[113569215] It was reported that on (b)(6) 2018, the patient was implanted with two (2) polyetheretherketone (peek) patient-specific implants (psi), a total of eight (8) matrixneuro plates (4 for each psi implant) and sixteen (16) matrixneuro screws during a bifrontal cranioplasty. After approximately one (1) month, implants were removed due to infection. The hardware removal was successfully completed on an unknown date. Revision surgery will be scheduled to insert a new flap once patient heals from infection. Patient outcome was satisfactory. This report is for one (1) titanium matrixneuro screw 4mm this is report 5 of 5 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2018-52783
MDR Report Key7674591
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-07-10
Date of Report2018-05-04
Date Mfgr Received2018-05-04
Date Added to Maude2018-07-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMICHAEL COTE
Manufacturer Street1302 WRIGHT LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
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 NameTI MATRIXNEURO SCREW SELF-DRILLING 4MM
Generic NamePLATE,CRANIOPLASTY,PREFORMED, ALTERABLE
Product CodeGWO
Date Received2018-07-10
Model Number04.503.104.01
Catalog Number04.503.104.01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2018-07-10

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