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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CNNLTD 5.5 PLYSCRW 6.5X45 PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

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ZIMMER BIOMET SPINE INC. CNNLTD 5.5 PLYSCRW 6.5X45 PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 3505-6545
Device Problems Detachment of Device or Device Component (2907); Migration (4003)
Patient Problem Tissue Damage (2104)
Event Date 01/26/2020
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 3012447612-2020-00139.

 
Event Description

It was reported that during a spinal fracture procedure, two screws backed out of the bone as the surgeon was tightening the closure tops over the rod. One of the screws was replaced with a larger diameter screw while the other screw required the surgeon to advance to an adjacent level to complete the case. Additionally, one of the removed screws was reported to have dissembled once removed. This is report one of two for this event.

 
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Brand NameCNNLTD 5.5 PLYSCRW 6.5X45
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
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key9753705
MDR Text Key180857196
Report Number3012447612-2020-00138
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number3505-6545
Device LOT NumberAAL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/20/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/11/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/28/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 02/26/2020 Patient Sequence Number: 1
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