TI MATRIXNEURO DOUBLE Y-PLATE 6 HOLES/21MM 04.503.069

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 2020-03-06 for TI MATRIXNEURO DOUBLE Y-PLATE 6 HOLES/21MM 04.503.069 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[182471379] Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is company representative. 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


[182471380] It was reported that on an unknown date, the patient underwent removal of the two (2) broken titanium matrixneuro double y-plate six holes attached to patient specific implants (psi). The cause of the breakage was unknown and when the implanted plates were broken. The patient had post initial surgery six (6) months ago. All hardware were removed and replaced without issue. There was no injury to patient. No fragments remained patient status is unknown. Concomitant devices reported: unknown screws (part# unknown, lot# unknown, quantity# unknown). This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01165
MDR Report Key9800027
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-06
Date of Report2020-02-10
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-06
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 ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1ELMIRA
Manufacturer Street35 AIRPORT ROAD
Manufacturer CityHORSEHEADS NY 14845
Manufacturer CountryUS
Manufacturer Postal Code14845
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTI MATRIXNEURO DOUBLE Y-PLATE 6 HOLES/21MM
Generic NameBONE PLATE
Product CodeJEY
Date Received2020-03-06
Model Number04.503.069
Catalog Number04.503.069
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
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 2020-03-06

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