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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 4.5MM X 45MM; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
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ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 4.5MM X 45MM; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 3505-4545
Device Problem Disassembly (1168)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2018
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 that the tulip of a pedicle screw was found to have detached after being installed in surgery.The screw was removed and replaced with an alternative screw to complete the procedure.There were no patient impacts reported in association with this event.
 
Manufacturer Narrative
Additional information: (ethnicity), (methods, results, and conclusions) - the polyaxial screw was returned for evaluation.The tulip head has disassembled from the shank.The cause of the disassembly is likely attributed to the deformation of the splines associated with final tightening and subsequent loosening of the rod and closure top within the tulip.A review of the dhr did not identify any issues which would have contributed to this event.
 
Event Description
It was reported that the tulip of a pedicle screw was found to have detached after being installed in surgery.The screw was removed and replaced with an alternative screw to complete the procedure.There were no patient impacts reported in association with this event.
 
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Brand Name
CANNULATED POLYAXIAL SCREW 4.5MM X 45MM
Type of Device
PATHFINDER 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 Key7621162
MDR Text Key111920832
Report Number3012447612-2018-00486
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3505-4545
Device Lot Number88MP
Other Device ID Number(01)00889024335592(10)88MP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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