6.5 X 50MM MULTIAXIAL SCREW 2000-2450

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-28 for 6.5 X 50MM MULTIAXIAL SCREW 2000-2450 manufactured by Zimmer Biomet Spine Inc..

Event Text Entries

[182702421] Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. Reference reports 3012447612-2020-00140 to 3012447612-2020-00149.
Patient Sequence No: 1, Text Type: N, H10


[182702422] It was reported that during a spondylolisthesis correction procedure, the tulip heads shifted allowing the rods to bend towards the vertebrae rather than the vertebrae shifting to the location of the rod. The correction of the deformity was ineffective, the implants were tightened and left in place to complete the case. There were no reported additional patient impacts and no revision is scheduled at this time. This is report one of ten.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012447612-2020-00140
MDR Report Key9770701
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2020-02-28
Date of Report2020-02-28
Date of Event2020-01-30
Date Mfgr Received2020-01-30
Date Added to Maude2020-02-28
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 ContactMS. ASHLEY MCPHERSON
Manufacturer Street10225 WESTMOOR DR. NA
Manufacturer CityWESTMINSTER CO 80021
Manufacturer CountryUS
Manufacturer Postal80021
Manufacturer Phone3034437500
Manufacturer G1ZIMMER BIOMET SPINE INC.
Manufacturer Street10225 WESTMOOR DR. NA
Manufacturer CityWESTMINSTER CO 80021
Manufacturer CountryUS
Manufacturer Postal Code80021
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand Name6.5 X 50MM MULTIAXIAL SCREW
Generic NameEBI 5.5 HELICAL FLANGE SPINAL SYSTEM
Product CodeMNH
Date Received2020-02-28
Model NumberNA
Catalog Number2000-2450
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET SPINE INC.
Manufacturer Address10225 WESTMOOR DR. WESTMINSTER CO 80021 US 80021


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-28

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