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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 9.5X70 VITALITY SPINAL FIXATION SYSTEM

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ZIMMER BIOMET SPINE INC. BOTTOM LOADING POLY OPEN ILIAC SCREW ASSEMBLIES 9.5X70 VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 07.02050.206
Device Problem Disassembly (1168)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2018
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.
 
Event Description
It was reported that a pedicle screw disassembled while being removed immediately after installation during surgery. The screw was removed and replaced with an alternative screw without reported patient impacts.
 
Manufacturer Narrative
Additional information: the iliac screw was not returned; however a photo of the device was provided and used for evaluation purposes. The tulip head was confirmed to be disassembled from the screw shank. The cause of this failure cannot be conclusively determined without evaluation of the complaint part. However, the disassembly was likely caused by removal of the fully implanted screw. Since the lot number is unknown, the dhr was unable to be reviewed.
 
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Brand NameBOTTOM LOADING POLY OPEN ILIAC SCREW ASSEMBLIES 9.5X70
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 Key7628989
MDR Text Key112003478
Report Number3012447612-2018-00522
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 09/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number07.02050.206
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 Received08/09/2018
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

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