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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL OPEN ILIAC SCREW, UNKNOWN SIZE VITALITY SPINAL FIXATION SYSTEM

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ZIMMER BIOMET SPINE INC. POLYAXIAL OPEN ILIAC SCREW, UNKNOWN SIZE VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 704MXXXX
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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. Reference reports: 3012447612-2020-00659.
 
Event Description
It was reported that a shear-off closure top backed out of its mating pedicle screw post-operatively. There are no plans to revise at this time. This is report two of two for this event.
 
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Brand NamePOLYAXIAL OPEN ILIAC SCREW, UNKNOWN SIZE
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
jessica buzbee
10225 westmoor dr.
na
westminster, CO 80021
3038034523
MDR Report Key10896064
MDR Text Key218014630
Report Number3012447612-2020-00660
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number704MXXXX
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 Received04/01/2021
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 Initial

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