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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET SPINE INC. CANNULATED PEDICLE SCREW, UNKNOWN SIZE PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/28/2018
Event Type  Malfunction  
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: 3012447612-2018-00431 thru 3012447612-2018-00447.

 
Event Description

It was reported that the threads of six closure tops fractured off, the tulips of six pedicle screws splayed open, and two sleeves would not attach to the pedicle screws during surgery. The procedure was completed using alternative closure tops, the same pedicle screws, and the sleeves were not used during the second half of the procedure. The closure tops installed within the six pedicle screws were not final tightened. There were no reports of patient impacts associated with this event. This is report 15 of 17 for this event.

 
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Brand NameCANNULATED PEDICLE 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
geoffrey gannon
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key7547859
MDR Text Key109365986
Report Number3012447612-2018-00445
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeBE
PMA/PMN NumberPK132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 05/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2018
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

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