SET SCREW 7601-10001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-16 for SET SCREW 7601-10001 manufactured by K2m, Inc..

Event Text Entries

[183766035] Remains implanted.
Patient Sequence No: 1, Text Type: N, H10


[183766036] Stryker representative reported that during patient's 6 week follow up, x-rays showed 4 yukon oct spinal system set screws at t1 and t2 had "become loose or completely disengaged" from the tulip head. Revision surgery has not been scheduled. This report represents the third of four screws.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004774118-2020-00032
MDR Report Key9835780
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2019-07-30
Date Mfgr Received2020-02-18
Date Added to Maude2020-03-16
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 ContactMR. RITA KARAN
Manufacturer Street2 PEARL COURT
Manufacturer CityALLENDALE NJ 07401
Manufacturer CountryUS
Manufacturer Postal07401
Manufacturer Phone2017608000
Manufacturer G1K2M, INC.
Manufacturer Street600 HOPE PARKWAY SE
Manufacturer CityLEESBURG VA 20175
Manufacturer CountryUS
Manufacturer Postal Code20175
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSET SCREW
Generic NamePOSTERIOR CERVICAL SCREW SYSTEM
Product CodeNKG
Date Received2020-03-16
Model Number7601-10001
Catalog Number7601-10001
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerK2M, INC.
Manufacturer Address600 HOPE PARKWAY SE LEESBURG VA 20175 US 20175


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-16

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