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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE CANNULATED 5.5 POLYAXIAL SCREW 6.5X45

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ZIMMER SPINE CANNULATED 5.5 POLYAXIAL SCREW 6.5X45 Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 03/18/2016
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. Report two of four for the same event; see also 0002184052-2016-00032, 00034 and 00035.
 
Event Description
The facility reported that the screw, rod and connector from lt l4 fusion were removed from patient due to pain. Procedure was a lumbar fusion.
 
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Brand NameCANNULATED 5.5 POLYAXIAL SCREW 6.5X45
Type of DeviceSCREW
Manufacturer (Section D)
ZIMMER SPINE
7375 bush lake road
minneapolis MN 55439
Manufacturer (Section G)
ZIMMER SPINE
7375 bush lake road
minneapolis MN 55439
Manufacturer Contact
michelle cole
7375 bush lake road
minneapolis, MN 55439
MDR Report Key5609486
MDR Text Key43696485
Report Number0002184052-2016-00033
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK132884
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 03/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number3505-6545
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
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 Received03/29/2016
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 Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/26/2016 Patient Sequence Number: 1
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