• 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 TAP DIA. 5.5MM VITALITY SPINAL FIXATION 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 TAP DIA. 5.5MM VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 735M0155
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/14/2020
Event Type  malfunction  
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. Reference reports 3012447612-2020-00650 thru 3012447612-2020-00654.
 
Event Description
It was reported that two 5. 5 diameter taps and guide wires broke while trying to tap l5. Also, a 7. 5 diameter tap broke while trying to tap the pelvis. The patient had very strong bone. There were no reports of patient impacts associated with the 5. 5 taps or the guide wires. However, the patient did retain a portion of the threads from the 7. 5 tap. This is report two of five for this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCANNULATED TAP DIA. 5.5MM
Type of DeviceVITALITY SPINAL FIXATION 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
jessica buzbee
10225 westmoor dr.
na
westminster, CO 80021
3038034523
MDR Report Key10820225
MDR Text Key216376446
Report Number3012447612-2020-00651
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number735M0155
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

-
-