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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CLOSURE TOP; VITALITY SPINAL FIXATION SYSTEM
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ZIMMER BIOMET SPINE INC. CLOSURE TOP; VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 07.02010.001
Device Problem Migration (4003)
Patient Problem No Code Available (3191)
Event Date 09/14/2020
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: 3012447612-2020-00598 to 3012447612-2020-00603.
 
Event Description
It was reported that the patient underwent a revision surgery after three vitality set screws were found to have migrated postoperatively.They were removed along with the three associated screws and replaced with alternates of the same size to complete the case.There were no additional patient impacts reported.This is report four of six for the event.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Additional in: h6: component,investigation type, findings, and conclusions.The complaint is unrefuted for three vitality closure tops for the failure of post-operative migration.This device is used for treatment.No medical records were provided with the complaint.Inspection the products were not returned, but a photo of an x-ray was provided.When reviewing the x-ray, it was unclear which closure tops loosened/migrated.The complaint remains unrefuted.Dhr review the lot numbers were not provided, so the dhrs could not be reviewed.Potential root cause a definitive root cause cannot be determined with the information provided.A follow-up report will be submitted if new information is received that changes the information provided in this report.
 
Event Description
It was reported that the patient underwent a revision surgery after three vitality set screws were found to have migrated postoperatively.They were removed along with the three associated screws and replaced with alternates of the same size to complete the case.There were no additional patient impacts reported.This is report four of six for the event.
 
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Brand Name
CLOSURE TOP
Type of Device
VITALITY SPINAL FIXATION SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10677862
MDR Text Key211286027
Report Number3012447612-2020-00601
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
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07.02010.001
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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