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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET SPINE INC. DIA 5.5 PRECUT CURVED RODS, TI ALLOY 55MM VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 07.02015.008
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 04/25/2017
Event Type  malfunction  
Manufacturer Narrative
The returned rods were examined. Investigation into the event and a review of the manufacturing records determined that the actual length of the rod, the part number etched on the rod, and the part number and description (including length) on the package label were all correct. However, the length etched on the rod was incorrect; the length was etched as 50mm instead of the actual and correct length of 55mm. The cause is attributed to a supplier manufacturing error during the etching process.
 
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 3012447612-2017-00129 and 3012447612-2017-00131 thru 3012447612-2017-00133.
 
Event Description
It was reported that four rods were found to be identified with the incorrect length while stocking them into sets. There was no patient involvement associated with this event. This is report three of four for this event.
 
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Brand NameDIA 5.5 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
geoffrey gannon
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key6603488
MDR Text Key133124572
Report Number3012447612-2017-00132
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK150896
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2017
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
Other Device ID Number(01)00889024003965(10)P142565
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2017
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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