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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ADJUSTABLE TRANSVERSE CONNECTOR, UNKNOWN SIZE VITALITY SPINAL FIXATION SYSTEM

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ZIMMER BIOMET SPINE INC. ADJUSTABLE TRANSVERSE CONNECTOR, UNKNOWN SIZE VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 08/19/2019
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. Reference reports 3012447612-2019-00492 to 3012447612-2019-00496. Mw5090392.
 
Event Description
It was reported that a patient underwent a revision surgery where three screws, a plug, and a transverse connector were removed. A vitality screw was found to be fractured and a polaris screw was found disassembled. There was no further surgical information provided this is report five of five.
 
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Brand NameADJUSTABLE TRANSVERSE CONNECTOR, 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
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key9387718
MDR Text Key168435988
Report Number3012447612-2019-00496
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
Type of Report Initial,Followup
Report Date 08/20/2020
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/20/2020
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
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