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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 45MM; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
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ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 6.5MM X 45MM; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 3505-6545
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/07/2020
Event Type  malfunction  
Manufacturer Narrative
Initial reporter: (b)(6).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 a pedicle screw disassembled after being installed intra-operatively.The screw was removed and replaced to completed the procedure.There were no abnormalities seen on the screw prior to usage.There were no reported patient health impacts.
 
Manufacturer Narrative
This follow-up report is being submitted to correct previously reported information.Corrections: d1; d4: catalog number, lot number, and udi number; and h4.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 a pedicle screw disassembled after being installed intra-operatively.The screw was removed and replaced to completed the procedure.There were no abnormalities seen on the screw prior to usage.There were no reported patient health impacts.
 
Manufacturer Narrative
Corrected information in d10 and h3.Additional information in h6: method, results, and conclusions.This follow-up report is being submitted to relay additional information.Device evaluation: the product number and lot numbers of the returned product match the complaint.Visual inspection reveals, the screw (item 3505-6540 lot 85he) is deformed with the shaft being disconnected from the tulip.The complaint is confirmed for disassembled.Complaint history search: the complaint history search was conducted.Dhr review and related actions: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this device is used for treatment.Potential cause: with the given information, the definitive cause cannot be determined.
 
Event Description
It was reported that a pedicle screw disassembled after being installed intra-operatively.The screw was removed and replaced to completed the procedure.There were no abnormalities seen on the screw prior to usage.There were no reported patient health impacts.
 
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Brand Name
CANNULATED POLYAXIAL SCREW 6.5MM 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
MDR Report Key10800577
MDR Text Key215035869
Report Number3012447612-2020-00647
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00889024335691
UDI-Public(01)00889024335691(10)85LR
Combination Product (y/n)N
PMA/PMN Number
K132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3505-6545
Device Lot Number85HE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age64 YR
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