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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. EXTENDER SLEEVE, REDUCTION STYLE, LONG PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

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ZIMMER BIOMET SPINE INC. EXTENDER SLEEVE, REDUCTION STYLE, LONG PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 3557-2300
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
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.

 
Event Description

It was reported an extender sleeve was found bent. There is no information available regarding the timing or usage of the device when it became bent.

 
Manufacturer Narrative

The returned sleeve was evaluated, the legs were found to be flared open, likely as the result of incorrect alignment of the sleeve with a mating pedicle screw during a previous usage of the device. A review of the dhr did not detect any manufacturing issues which would have contributed to this event.

 
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Brand NameEXTENDER SLEEVE, REDUCTION STYLE, LONG
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 Key7160826
MDR Text Key96368707
Report Number3012447612-2018-00003
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodePL
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,Followup
Report Date 08/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number3557-2300
Device LOT Number84QF
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/28/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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