• 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. ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 36-41 WIDE X 5.5 MM ROD 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. ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 36-41 WIDE X 5.5 MM ROD VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 07.02030.002
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2022
Event Type  malfunction  
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. Reference reports 3012447612-2022-00147 through 3012447612-2022-00149.
 
Event Description
It was reported that three vitality connectors stripped intra-operatively; the screw driver kept turning with all three. They were each removed and replaced with a fourth connector to complete the procedure without patient impacts. This is report three of three for this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 36-41 WIDE X 5.5 MM ROD
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
kim martinez
10225 westmoor dr.
na
westminster, CO 80021
3035144809
MDR Report Key14464570
MDR Text Key294657133
Report Number3012447612-2022-00149
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00889024007451
UDI-Public(01)00889024007451(10)W724491(11)200310
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150896
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number07.02030.002
Device Lot NumberW724491
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-