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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET SPINE EXTENDER SLEEVE REDUCTION STYLE- LONG PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 3557-2300
Device Problem Device Inoperable (1663)
Patient Problem No Code Available (3191)
Event Date 07/08/2016
Event Type  Injury  
Manufacturer Narrative
The returned sleeve was examined. There was evidence of use (scratches) but no signs of damage or deformation. When functionally tested with mating parts, the connection between the sleeve and the pedicle screw was slightly loose, allowing the screw to wiggle slightly, but the device was operational. A review of the manufacturing records did not identify any issues which may have contributed to this event. The labeling was reviewed and found to contain sufficient instructions regarding proper device usage. Reference reports 0002184052-2016-00150 and 3004485144-2016-00404.
 
Event Description
The sales associate reported non-functional instruments. During a case, the sleeves were unable to be used during the nxt case. It was reported that the sleeves have started to splay at the bottom, not allowing the screws to sit in the grooves correctly and therefore not letting the screwdrivers to be seated in the screw head. The surgery was completed using the short sleeves and pins. The doctor had to change technique from true percutaneous because the short sleeves were not long enough for the obese patient to allow a mini open type approach. This is report three of three for 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
310 interlocken parkway
suite 120
broomfield CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE
310 interlocken parkway
suite 120
broomfield CO 80021
Manufacturer Contact
geoffrey gannon
310 interlocken parkway
suite 120
broomfield, CO 80021
3034437500
MDR Report Key6198711
MDR Text Key63103272
Report Number3004485144-2016-00405
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 12/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3557-2300
Device Lot Number66CDR
Other Device ID Number(01)00889024336346
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/22/2016 Patient Sequence Number: 1
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