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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 PRECUT CURVED RODS, TI ALLOY 55MM VITALITY SPINAL FIXATION SYSTEM

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ZIMMER BIOMET SPINE INC. 5.5 PRECUT CURVED RODS, TI ALLOY 55MM VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 07.02015.008
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Date 11/28/2019
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. Reference report 3012447612-2019-00548.
 
Event Description
It was reported that a hospital received the incorrect product in two packages. The packages contained 50mm rods instead of the labeled 55mm rods. The product was discovered by the hospital complainant and there was no reported patient involvement. This is report one of two.
 
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Brand Name5.5 PRECUT CURVED RODS, TI ALLOY 55MM
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
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key9501511
MDR Text Key175242483
Report Number3012447612-2019-00547
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00889024003965
UDI-Public(01)00889024003965(10)P142565
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K150896
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 06/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number07.02015.008
Device Lot NumberP142565
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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