• 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 EXTENDER SLEEVE REDUCTION STYLE- LONG

  • 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 EXTENDER SLEEVE REDUCTION STYLE- LONG Back to Search Results
Model Number N/A
Device Problems Break (1069); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/18/2016
Event Type  malfunction  
Manufacturer Narrative
The customer was unable to provide any details relating to this device at this time. Without a product return, no product evaluation is able to be conducted. The user facility is foreign; therefore a facility medwatch report will not be available. 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. Report two of two for the same event, reference (b)(4).
 
Event Description
It is reported the extender was placed on l4 on the right and surgeon tried to set three closure tops using the closure top driver, however the threads collapsed. A new closure top was used to complete the surgery. It is reported the extender sleeve broke, however no additional information was available at this time.
 
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 device was examined. There were no visual discrepancies found. It was functionally checked using mating parts and found to function as expected. No failures were found and the complaint cannot be confirmed. A review of the manufacturing records did not identify any issues in relation to the reported event. The labeling was reviewed and found to contain sufficient instructions regarding proper device usage.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEXTENDER SLEEVE REDUCTION STYLE- LONG
Type of DeviceEXTENDER SLEEVE
Manufacturer (Section D)
ZIMMER SPINE
7375 bush lake road
minneapolis MN 55439
Manufacturer (Section G)
ZIMMER SPINE
7375 bush lake road
minneapolis MN 55439
Manufacturer Contact
michelle cole
7375 bush lake road
minneapolis, MN 55439
9528325600
MDR Report Key5667503
MDR Text Key45537012
Report Number0002184052-2016-00056
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
PK132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number3557-2300
Device Lot Number83LX
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/19/2016 Patient Sequence Number: 1
-
-