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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. OPEN IMPLANT CLOSURE TOP SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

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ZIMMER BIOMET SPINE INC. OPEN IMPLANT CLOSURE TOP SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM Back to Search Results
Catalog Number 3301-1
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). 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 report: 3012447612-2018-00540.

 
Event Description

It was reported that two closure tops did not install correctly during surgery. They were removed and replaced with alternative closure tops to complete the procedure without reported patient impacts. This is report one of two for this event.

 
Manufacturer Narrative

Additional information: (ethnicity), (methods, results, and conclusions) - the device was not returned so an evaluation was unable to be performed, no results are available, and no conclusions can be drawn. A review of the dhr did not identify any manufacturing issues which would have contributed to this event.

 
Event Description

It was reported that two closure tops did not install correctly during surgery. They were removed and replaced with alternative closure tops to complete the procedure without reported patient impacts. This is report one of two for this event.

 
Manufacturer Narrative

The closure top was returned for evaluation. The threads were found to have fractured off. Based on the event description and the nature of the thread failure, it is likely the failure is due to misalignment between the closure top and pedicle screw tulip head.

 
Event Description

It was reported that two closure tops did not install correctly during surgery. They were removed and replaced with alternative closure tops to complete the procedure without reported patient impacts. This is report one of two for this event.

 
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Brand NameOPEN IMPLANT CLOSURE TOP
Type of DeviceSEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
geoffrey gannon
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key7655000
MDR Text Key112886701
Report Number3012447612-2018-00539
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeRS
PMA/PMN NumberPK131980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number3301-1
Device LOT NumberAAD
OTHER Device ID Number(01)00889024334861(10)ADD
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/17/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/24/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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