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

MAUDE Adverse Event Report: ZIMMER SPINE TL PEDICLE SCREW, DIA 6.5 X 45MM JAVA TOP LOADING

  • 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 SPINE TL PEDICLE SCREW, DIA 6.5 X 45MM JAVA TOP LOADING Back to Search Results
Catalog Number SN2023-0-24565
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 04/11/2017
Event Type  Injury  
Manufacturer Narrative
This device is not cleared for use in or marketed within the us. It is a similar product to those cleared by k111301 under product code nkb. 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 reports 3003853072-2017-00049 thru 3003853072-2017-00051.
 
Event Description
It was reported that three pedicle screws fractured post-operatively. The screws were installed for approximately three years prior to the breakage. A revision surgery was performed to address the broken screws. There were no other reports of patient injury associated with this event. This is report one of three for this event.
 
Manufacturer Narrative
The device was not returned for evaluation, however photographs were provided and used for the evaluation. The threaded shaft had fractured; the complaint is confirmed. The fractured screws were found four years after being implanted and bony fusion was achieved at the site. It cannot be concluded that the screws broke before the fusion occurred. A review of the device labeling shows that this is a known risk of the procedure since repeated stresses on the devices over time can lead to device fracture. A review of the manufacturing records did not identify any issues which would have contributed to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTL PEDICLE SCREW, DIA 6.5 X 45MM
Type of DeviceJAVA TOP LOADING
Manufacturer (Section D)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux, cedex 33080
FR 33080
Manufacturer (Section G)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux, cedex 33080
FR 33080
Manufacturer Contact
teresa george
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key6570786
MDR Text Key75305437
Report Number3003853072-2017-00049
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
PNA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSN2023-0-24565
Device Lot NumberH17610B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2012
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: 05/16/2017 Patient Sequence Number: 1
-
-