SELF-STARTING, VARIABLE SCREW; SIZE ?4.0X16 MM 8801-04016DA

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 2020-03-18 for SELF-STARTING, VARIABLE SCREW; SIZE ?4.0X16 MM 8801-04016DA manufactured by K2m, Inc..

Event Text Entries

[184055774] Device remains implanted in patient.
Patient Sequence No: 1, Text Type: N, H10


[184055775] A physician reported two ozark screws were noted to be fractured post-operatively. It is not known if revision surgery will be performed. This report represents the second of two screws.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004774118-2020-00042
MDR Report Key9850217
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-18
Date of Report2020-03-18
Date of Event2020-02-20
Date Mfgr Received2020-02-20
Date Added to Maude2020-03-18
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 NameSELF-STARTING, VARIABLE SCREW; SIZE ?4.0X16 MM
Generic NameAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Product CodeKWQ
Date Received2020-03-18
Model Number8801-04016DA
Catalog Number8801-04016DA
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 2020-03-18

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