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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5X55MM CURVED TITANIUM ROD VITALITY SPINAL FIXATION SYSTEM

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ZIMMER BIOMET SPINE INC. 5.5X55MM CURVED TITANIUM ROD 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 08/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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.
 
Event Description
It was reported a package labeled as a 55m rod actually contained a 50mm rod. This was identified at the warehouse.
 
Manufacturer Narrative
Udi number: (b)(4). Additional information: (method, results, conclusions) - the returned rod was evaluated. A review of the manufacturing records determined that the length of the rod matched the part number etched on the rod, and also matched the part number and description on the package label; however, the length etched on the rod is incorrect. It was etched as 50mm instead of the correct length of 55mm. The cause is attributed to a manufacturing error during the etching process.
 
Event Description
It was reported a package labeled as a 55m rod actually contained a 50mm rod. This was identified at the warehouse.
 
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Brand Name5.5X55MM CURVED TITANIUM 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
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key7896342
MDR Text Key120973441
Report Number3012447612-2018-00774
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
PK150896
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 11/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2018
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 Manufacturer10/10/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/09/2018
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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