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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ARRAY SCREW, UNKNOWN SIZE OR TYPE EBI TOP LOADING MAS SPINAL FIXATION SYSTEM

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ZIMMER BIOMET SPINE INC. ARRAY SCREW, UNKNOWN SIZE OR TYPE EBI TOP LOADING MAS SPINAL FIXATION SYSTEM Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Stenosis (2263)
Event Date 06/07/2021
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.
 
Event Description
It was reported that a revision surgery was performed to remove an array screw at the right side of l4 after a patient developed stenosis in the treated level (l3/4).
 
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Brand NameARRAY SCREW, UNKNOWN SIZE OR TYPE
Type of DeviceEBI TOP LOADING MAS 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 Key12569574
MDR Text Key274535881
Report Number3012447612-2021-00386
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K033312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received09/07/2021
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

Patient Treatment Data
Date Received: 10/04/2021 Patient Sequence Number: 1
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