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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. BOTTOM LOADING POLY OPEN ILIAC SCREW ASSEMBLIES 9.5X90 VITALITY SPINAL FIXATION SYSTEM

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ZIMMER BIOMET SPINE INC. BOTTOM LOADING POLY OPEN ILIAC SCREW ASSEMBLIES 9.5X90 VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 07.02050.210
Device Problems Disassembly (1168); Material Deformation (2976)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/03/2018
Event Type  Injury  
Manufacturer Narrative
The surgeon stated that the screw head started to hit the ilium as he was advancing the screw and this may have been a contributing factor to the screw becoming stuck within the patient's bone. 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. Reference reports 3012447612-2018-00456 thru 3012447612-2018-00459.
 
Event Description
It was reported that a pedicle screw was difficult to install during surgery and the tip of one driver broke while attempting to install the screw. Once the driver was removed, the tulip of the pedicle screw disassembled from the shaft. Two drivers started to shear while trying to remove the screw shaft, but the screw shaft could not be removed and remains implanted. There were no reported patient impacts outside of the remaining screw shaft. This is report one of four for this event.
 
Manufacturer Narrative
The product was not returned and no photos were provided, so an evaluation could not be performed. As such, no evaluation results are available and no conclusions regarding the cause can be drawn. The lot number was not provided, so the manufacturing records could not be reviewed.
 
Event Description
It was reported that a pedicle screw was difficult to install during surgery and the tip of one driver broke while attempting to install the screw. Once the driver was removed, the tulip of the pedicle screw disassembled from the shaft. Two drivers started to shear while trying to remove the screw shaft, but the screw shaft could not be removed and remains implanted. There were no reported patient impacts outside of the remaining screw shaft. This is report one of four for this event.
 
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Brand NameBOTTOM LOADING POLY OPEN ILIAC SCREW ASSEMBLIES 9.5X90
Type of DeviceVITALITY SPINAL FIXATION 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 Key7571858
MDR Text Key110166715
Report Number3012447612-2018-00456
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK150896
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number07.02050.210
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/24/2018
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

Patient Treatment Data
Date Received: 06/05/2018 Patient Sequence Number: 1
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