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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 6.5MM X 50MM PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

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ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 6.5MM X 50MM PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 3505-6550
Device Problems Disassembly (1168); Mechanical Jam (2983)
Patient Problem No Code Available (3191)
Event Date 03/21/2018
Event Type  Injury  
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. Reference report 3012447612-2018-00352.
 
Event Description
It was reported that the tulip of a pedicle screw disassembled from its shaft and became stuck in a reduction sleeve during surgery. There was a delay greater than 30 minutes associated with removing the screw shank and replacing the screw with an alternative pedicle screw. However, no patient harm was reported. This is report one of two for this event.
 
Manufacturer Narrative
The tulip portion of the pedicle screw was returned and was found to be wedged within the mating sleeve. The threaded shaft had disassembled from the tulip and was not returned. The threads within the tulip were found damaged in a manner consistent with cross-threading the closure top within the tulip during tightening. The tulip was wedged within the sleeve because of thread fragments apparently from the closure top which was stuck between the sleeve and tulip. It was likely that the sleeve and pedicle screw were not appropriately aligned, which led to the cross-threading, damaged threads, fractured threads, and disassembly. A review of the dhr did not identify any issues which would have contributed to this event.
 
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Brand NameCANNULATED POLYAXIAL SCREW 6.5MM X 50MM
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 Key7432252
MDR Text Key105520009
Report Number3012447612-2018-00351
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 08/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3505-6550
Device Lot Number85LX
Other Device ID Number(01)00889024335714(10)85LX
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/16/2018 Patient Sequence Number: 1
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