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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET SPINE INC. VITAL MIS POLYAXIAL SCREW, UNKNOWN SIZE VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 824MXXXX
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Spinal Column Injury (2081)
Event Type  Injury  
Event Description
It was reported that two pedicle screws pulled out of the bone intra-operatively, compromising the bone. The patient had very bone quality. No further information has been provided. This is report two of two for this event.
 
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted. 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 3012447612-2021-00432.
 
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Brand NameVITAL MIS POLYAXIAL 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
kim martinez
10225 westmoor dr.
na
westminster, CO 80021
3035144809
MDR Report Key12828535
MDR Text Key280883383
Report Number3012447612-2021-00433
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number824MXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/15/2022
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: 11/17/2021 Patient Sequence Number: 1
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