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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 Problem Device Operates Differently Than Expected (2913)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 12/11/2017
Event Type  Injury  
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.
 
Manufacturer Narrative
The returned pedicle screw was evaluated. The tulip threads were found damaged in a manner consistent with cross-threading. The tulip was disassembled from the shaft due to deformation of the shaft splines and swivel ring in a manner consistent with locking and subsequent unlocking of the screw with the mating rod and closure top. A review of the manufacturing records did not identify any issues which would have contributed to this event.
 
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. (b)(4).
 
Event Description
It was reported that the threads of a closure top were damaged during installation into the mating pedicle screw in surgery. The closure top needed to be cut to be removed and the pedicle screw was also removed. An alternative screw and closure top were used to complete the procedure. There was a surgical delay greater than 30 minutes and the patient retained a device fragment. No further patient impact was reported. This is report two of two for 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 Key7180368
MDR Text Key108417612
Report Number3012447612-2018-00034
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
PK132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3505-6550
Device Lot Number80SF
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2014
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: 01/10/2018 Patient Sequence Number: 1
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