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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE CNNLTD 5.5 PLYSCRW 6.5X50 PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

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ZIMMER BIOMET SPINE CNNLTD 5.5 PLYSCRW 6.5X50 PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Model Number N/A
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/03/2016
Event Type  Injury  
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. This is report one of four for this event. Reference reports 3004485144-2016-00361 thru 3004485144-2016-00364.
 
Event Description
It was reported that a pedicle screw disassembled while trying to further install it into the pedicle after initial placement. Additionally, three closure tops fractured during final tightening within the same procedure. The three closure tops and pedicle screw were replaced. There were no reports of patient harm associated with this event, however the surgery was delayed by 45 minutes.
 
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 screw was evaluated. The tulip head had disassembled from the screw shaft; the complaint is confirmed. A review of the manufacturing records did not identify any issues which would have contributed to this event. The labeling was reviewed and found to contain instructions regarding proper device usage, including the instruments which should be used for adjustments to the screw's position. However, these instructions were not followed and the complainant has been notified.
 
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Brand NameCNNLTD 5.5 PLYSCRW 6.5X50
Type of DevicePATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE
310 interlocken parkway
suite 120
broomfield CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE
310 interlocken parkway
suite 120
broomfield CO 80021
Manufacturer Contact
geoffrey gannon
310 interlocken parkway
suite 120
broomfield, CO 80021
3034437500
MDR Report Key6168327
MDR Text Key62183784
Report Number3004485144-2016-00361
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSZ
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 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number3505-6550
Device Lot Number84ES
Other Device ID Number(01)00889024335714
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2015
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: 12/12/2016 Patient Sequence Number: 1
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