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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREWDRIVER REDUCTION STYLE PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

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ZIMMER BIOMET SPINE INC. SCREWDRIVER REDUCTION STYLE PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 3558-2
Device Problem Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2018
Event Type  malfunction  
Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation. Reference reports 3012447612-2018-00576 thru 3012447612-2018-00583.
 
Event Description
It was reported that the threads of three closure tops, one pedicle screw, and three sleeves were damaged during surgery. Additionally, a screw driver was worn. The closure tops and screw were removed and replaced with an alternative screw and closure top. An alternative sleeve and screw driver were used to complete to procedure. There were no reported patient impacts associated with this event. This is report eight of eight for this event.
 
Manufacturer Narrative
Additional information: method, results, and conclusions - the returned device was evaluated. There was no failure mode detected. A review of the manufacturing records did not identify any issues which may have contributed to this event.
 
Event Description
It was reported that the threads of three closure tops, one pedicle screw, and three sleeves were damaged during surgery. Additionally, a screw driver was worn. The closure tops and screw were removed and replaced with an alternative screw and closure top. An alternative sleeve and screw driver were used to complete to procedure. There were no reported patient impacts associated with this event. This is report eight of eight for this event.
 
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Brand NameSCREWDRIVER REDUCTION STYLE
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
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key7763388
MDR Text Key116543049
Report Number3012447612-2018-00583
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,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3558-2
Device Lot Number84YD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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