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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET SPINE OPEN IMPLANT CLOSURE TOP SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM Back to Search Results
Model Number N/A
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2016
Event Type  malfunction  
Manufacturer Narrative
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. This is report two of six for this event. Reference reports 3004485144-2016-00367 thru 3004485144-2016-00368 and 3004485144-2016-003070 thru 3004485144-2016-00373.
 
Event Description
It was reported that the closure tops were stripping within the extension sleeves. The closure tops were replaced and the final tightening was performed with the counter torque instead of the sleeves. There was no patient injury reported with 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
310 interlocken parkway
suite 120
broomfield CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE
310 interlocken parkway
suite 120
broomfield CO 80021
Manufacturer Contact
geoffrey gannon
310 interlocken parkway
suite 120
broomfield, CO 80021
3034437500
MDR Report Key6171931
MDR Text Key62338671
Report Number3004485144-2016-00368
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK131980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 12/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number3301-1
Device Lot NumberUNKNOWN
Other Device ID Number(01)00889024334861
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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