2.0MM TI MF CORTEX SCREW SELF-TAPPING WITH FLUTES 6MM 401.156E

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 2019-03-14 for 2.0MM TI MF CORTEX SCREW SELF-TAPPING WITH FLUTES 6MM 401.156E manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[138807152] Additional device product code: hwc, mqn, jey. Implanted in (b)(6) 2018; exact date is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). 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


[138807153] It was reported on an unknown date; the patient underwent hardware removal procedure due to infection. There two (2)titanium broad plate 6 holes, one (1)titanium large locking plate 12 holes, five (5) titanium coretx screw self-tapping with flutes 6mm, one (1) titanium emergency screw 6mm, five (5) titanium cortex screw coarse pitch self-tapping 12mm, two (2) titanium cortex screw coarse pitch self-tapping 14mm, one (1) titanium cortex screw coarse pitch self-tapping 10mm, four (4) titanium emergency screw 12mm implanted in (b)(6) 2018. One of the three plates implanted became infected, and patient wanted them to be removed. The procedure was successfully completed with four (4) hours surgical delay. Patient outcome was unknown. This complaint involves total twenty-one (21) devices. This complaint captures ten (10) devices. Due to system limitation remaining eleven (11) devices are captured in the related complaints (b)(4). This report is for one (1) 2. 0mm ti cortex screw self-tapping with flutes 6mm. This is report 6 of 10 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2019-56961
MDR Report Key8421126
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-03-14
Date of Report2019-02-20
Date Mfgr Received2019-03-22
Date Added to Maude2019-03-14
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 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 Name2.0MM TI MF CORTEX SCREW SELF-TAPPING WITH FLUTES 6MM
Generic NameSCREW FIXATION INTRAOSSEOUS
Product CodeDZL
Date Received2019-03-14
Model Number401.156E
Catalog Number401.156E
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 2019-03-14

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