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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SEQUOIA TI POLY SCREW ASSX45; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

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ZIMMER BIOMET SPINE INC. SEQUOIA TI POLY SCREW ASSX45; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM Back to Search Results
Catalog Number 3306-6545
Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907)
Patient Problem Tissue Damage (2104)
Event Date 10/19/2019
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
It was reported that during a revision surgery to reposition a screw that had initially been positioned incorrectly, the screw disassembled.They created a new channel and inserted a larger screw to complete the procedure.There were no reported surgical delays or additional patient impacts.
 
Manufacturer Narrative
Additional information in d4 (udi), h4, h6 (method, results, and conclusions).The screw was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the dhr did not find any issues which would have contributed to this event.
 
Event Description
It was reported that during a revision surgery to reposition a screw that had initially been positioned incorrectly, the screw disassembled.They created a new channel and inserted a larger screw to complete the procedure.There were no reported surgical delays or additional patient impacts.
 
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Brand Name
SEQUOIA TI POLY SCREW ASSX45
Type of Device
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key9338728
MDR Text Key166932371
Report Number3012447612-2019-00442
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K131980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3306-6545
Device Lot NumberT09343
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/19/2019
Initial Date FDA Received11/18/2019
Supplement Dates Manufacturer Received02/03/2020
Supplement Dates FDA Received03/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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