• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. VITALITY SCREW, UNKNOWN SIZE OR TYPE VITALITY SPINAL FIXATION SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET SPINE INC. VITALITY SCREW, UNKNOWN SIZE OR TYPE VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Post Operative Wound Infection (2446); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Pma/510(k) number: k150896 or k171907. 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 report: 3012447612-2019-00465. - attachment: [mw5090361. Pdf].
 
Event Description
It was reported that a patient underwent a revision surgery to remove two vitality screws due to a post-op infection. There was no further surgical information provided and no additional patient impacts reported. This is report one of two.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVITALITY SCREW, UNKNOWN SIZE OR TYPE
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 Key9385840
MDR Text Key168437390
Report Number3012447612-2019-00464
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
SEE H10
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 Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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: 11/27/2019 Patient Sequence Number: 1
-
-