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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE SEQ POLY SCREW ASSY 5.5 X 40 SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

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ZIMMER BIOMET SPINE SEQ POLY SCREW ASSY 5.5 X 40 SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM Back to Search Results
Model Number N/A
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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 the tulip separated from the screw shaft during a procedure. It was removed from the patient and replaced. There were no reports of patient injury or surgical delay associated with this event.
 
Manufacturer Narrative
The device was not returned for evaluation. A review of the manufacturing records did not identify any issues which would have contributed to this event.
 
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Brand NameSEQ POLY SCREW ASSY 5.5 X 40
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 Key6167586
MDR Text Key62331521
Report Number3004485144-2016-00359
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK131980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number3306-5540
Device Lot Number85JP
Other Device ID Number(01)00889024334953
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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