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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
Model Number N/A
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 08/20/2018
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. Reference reports 3012447612-2018-00767, 3012447612-2018-00769, and 3012447612-2018-00770.
 
Event Description
It was reported that three rods were found to be identified with the incorrect length during a check. There was no patient involvement associated with this event. This is report three of three for this event.
 
Manufacturer Narrative
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 laser marked on the rod, and also matched the part number and description on the package label; however, the length marked on the rod is incorrect. It was marked as 50mm instead of the correct length of 55mm. The cause is attributed to a manufacturing error during the laser marking process.
 
Event Description
It was reported that three rods were found to be identified with the incorrect length during a check. There was no patient involvement associated with this event. This is report three of three 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
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key7890791
MDR Text Key120832209
Report Number3012447612-2018-00770
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 foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
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? Yes
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
Removal/Correction NumberN/A

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