• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED DORSAL HEIGHT & REVISION DRIVER; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET SPINE INC. CANNULATED DORSAL HEIGHT & REVISION DRIVER; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 3558-50
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2018
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 tip of a driver broke off in a screw head while adjusting the height of the screw during surgery.The screw was removed and replaced with an alternative screw to complete the procedure, so the patient did not retain the device fragment.There were no reported patient impacts associated with this event.
 
Manufacturer Narrative
Udi number: na.Additional information: method, results, and conclusions - the returned driver was examined.A portion of the tip has fractured off of one side, indicating that an off-axis force was applied to the device during usage.There were no manufacturing issues detected which would have contributed to this event.
 
Event Description
It was reported that the tip of a driver broke off in a screw head while adjusting the height of the screw during surgery.The screw was removed and replaced with an alternative screw to complete the procedure, so the patient did not retain the device fragment.There were no reported patient impacts associated with this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CANNULATED DORSAL HEIGHT & REVISION DRIVER
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
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key8182057
MDR Text Key130972348
Report Number3012447612-2018-01015
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3558-50
Device Lot Number69HX
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/20/2018
Initial Date FDA Received12/19/2018
Supplement Dates Manufacturer Received04/10/2019
Supplement Dates FDA Received04/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-