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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. TOP LOADING POLY SCREW ASSEMBLIES 6.5X40MM; VITALITY SPINAL FIXATION SYSTEM
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ZIMMER BIOMET SPINE INC. TOP LOADING POLY SCREW ASSEMBLIES 6.5X40MM; VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 07.02000.074
Device Problem Fracture (1260)
Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 07/24/2020
Event Type  Injury  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 3012447612-2020-00475 to 3012447612-2020-00484.
 
Event Description
It was reported that a patient underwent a revision surgery to address psuedoarthrosis and during the procedure it was discovered that the right s1 vitality pedicle screw was broken.The screw was removed and replaced with an alternate larger diameter screw to complete the case.There were no additional patient impacts reported.This is report one of ten for this event.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d4, d10, g4, g7, h2, h10.
 
Event Description
No further event information available at the time of this report.
 
Event Description
It was reported that a patient underwent a revision surgery to address psuedoarthrosis and during the procedure it was discovered that the right s1 vitality pedicle screw was broken.The screw was removed and replaced with an alternate larger diameter screw to complete the case.There were no additional patient impacts reported.This is report one of ten for this event.
 
Manufacturer Narrative
Additional information: d4(udi number), h3, h4, h6:evaluation codes: (methods, results, conclusions).Visual examination of the returned vitality screws identified that one of the screws has fully snapped, with the shaft disconnected from the screw head/tulip.The others appear to be without deformities.Functional investigation with 40 mm rod p142562 and closure top pn:07.02010.001 ln: w449491 showed that all tulip heads could thread and hold closure tops with rods.Visual examination of the returned vitality closure tops identified that the caps have been used before.Functional investigation with tulip head and screw pn: 701m6545 ln:t09925 and 40 mm rod p142562 showed that all four caps were fully functional.The complaint is confirmed.Review of the device history records for the four screws identified no deviations or anomalies during manufacturing.Lot identification is necessary for review of device history records, and lot identification could not be determined for the closure tops or the rods.Devices are used for treatment.The reported products were reviewed for compatibility with no issues noted.Review of complaint history identified additional similar complaints for the pn 07.02000.074 and 07.02000.075 and no additional complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Review of complaint history identified additional similar complaints for the pn 07.02010.001.However, as the lot number is unknown, an additional review could not be performed.Review of complaint history identified no additional similar complaints for the pn 07.02015.005.However, as the lot number is unknown, an additional review could not be performed.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
 
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Brand Name
TOP LOADING POLY SCREW ASSEMBLIES 6.5X40MM
Type of Device
VITALITY SPINAL FIXATION SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10440332
MDR Text Key204021216
Report Number3012447612-2020-00475
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K150896
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup,Followup
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07.02000.074
Device Lot NumberT8909
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/27/2020
Initial Date FDA Received08/21/2020
Supplement Dates Manufacturer Received08/25/2020
10/05/2020
Supplement Dates FDA Received09/09/2020
10/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age49 YR
Patient Weight89
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