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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLY SCREW, UNKNOWN SIZE PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

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ZIMMER BIOMET SPINE INC. CANNULATED POLY SCREW, UNKNOWN SIZE PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 3505-XXXX
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 10/07/2020
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 address post-operative pain associated with a screw that was possibly loose. The affected levels fused prior to the revision.
 
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Brand NameCANNULATED POLY SCREW, UNKNOWN SIZE
Type of DevicePATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW 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
jessica buzbee
10225 westmoor dr.
na
westminster, CO 80021
3038034523
MDR Report Key10960569
MDR Text Key219985229
Report Number3012447612-2020-00669
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3505-XXXX
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 Received02/09/2021
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: 12/07/2020 Patient Sequence Number: 1
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