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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 PRECUT CURVED RODS, TI ALLOY 110MM VITALITY SPINAL FIXATION SYSTEM

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ZIMMER BIOMET SPINE INC. 5.5 PRECUT CURVED RODS, TI ALLOY 110MM VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 07.02015.019
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 08/29/2019
Event Type  Injury  
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. 3012447612-2019-00459 and 3012447612-2019-00460.
 
Event Description
It was reported that a patient underwent a revision surgery to remove a pedicle screw, closure top, and rod. There was no further surgical or patient information was provided. This is report three of three.
 
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Brand Name5.5 PRECUT CURVED RODS, TI ALLOY 110MM
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
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key9380567
MDR Text Key168189560
Report Number3012447612-2019-00462
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150896
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 08/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number07.02015.019
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/14/2020
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

Patient Treatment Data
Date Received: 11/26/2019 Patient Sequence Number: 1
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