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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2022
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed to address a closure top that migrated out of the screw at s1.At the patient's post-operative follow-up appointment, the x-ray revealed the closure top was backing out of the screw.The construct was from l2-s1.Patient was revised with a new screw at the s1 level with all new closure tops on that side of the construct.This is report one of two for this event.
 
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 report 3012447612-2022-00174.
 
Event Description
It was reported that a revision surgery was performed to address a closure top that migrated out of the screw at s1.At the patient's post-operative follow-up appointment, the x-ray revealed the closure top was backing out of the screw.The construct was from l2-s1.Patient was revised with a new screw at the s1 level with all new closure tops on that side of the construct.This is report one of two for this event.
 
Manufacturer Narrative
Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Inspection: visual inspection revealed no clear issues with the devices.No x-ray images were provided for review.The complaint remains unrefuted for post-op migration of the closure top.Dhr review: the dhrs were reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimvie¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to the closure top not being tightened enough during the initial surgery.Device usage this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
 
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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
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
kim martinez
10225 westmoor dr.
na
westminster, CO 80021
3035144809
MDR Report Key14982935
MDR Text Key295679998
Report Number3012447612-2022-00173
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00889024003170
UDI-Public(01)00889024003170(10)W782141(11)210827
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150896
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/04/2022
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 Number07.02010.001
Device Lot NumberW782141
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/16/2022
Initial Date FDA Received07/11/2022
Supplement Dates Manufacturer Received10/25/2022
Supplement Dates FDA Received11/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient SexFemale
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