SEQUOIA OPEN CLOSURE, 5.5M, TOP TI 3301-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for SEQUOIA OPEN CLOSURE, 5.5M, TOP TI 3301-1 manufactured by Zimmer Biomet Spine Inc..

Event Text Entries

[186110661] Without a product return, no product evaluation is able to be conducted. 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 3012447612-2020-00189 to 3012447612-2020-00191.
Patient Sequence No: 1, Text Type: N, H10


[186110662] It was reported that during the procedure the threads of three closure tops were damaged during the final torquing step. There was a greater than 30 minute delay while they were being replaced without reported patient harm. This is report three of three for this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012447612-2020-00191
MDR Report Key9876258
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-02-15
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-24
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 NameSEQUOIA OPEN CLOSURE, 5.5M, TOP TI
Generic NameSEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
Product CodeNKB
Date Received2020-03-24
Model NumberNA
Catalog Number3301-1
Lot NumberAAS
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 2020-03-24

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