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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
Model Number N/A
Device Problem Migration (4003)
Patient Problems Unspecified Infection (1930); Pain (1994)
Event Date 03/16/2021
Event Type  Injury  
Manufacturer Narrative
Reference report 3012447612-2021-00197.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.
 
Event Description
It was reported that a revision was performed for pain, further decompression, and infection.During the revision surgery, the closure top was found to have migrated out of one of the screws at left s1.Prior to the revision, the patient twisted and felt pain.The physician had to wire the construct to hold it together since the set screw backed out.There was a delay of 30 minutes during the revision surgery.This is report one of two for this event.
 
Manufacturer Narrative
Additional information in h6: component codes, type of investigations, findings, and conclusions.Device evaluation: product was not returned and photos and x-rays were not provided, so a device evaluation could not be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to unknown adverse events, patient factors or operational factors.Dhr review : lot numbers are not known, so dhr review could not be performed.Device use : this device is used for treatment.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 a revision was performed for pain, further decompression, and infection.During the revision surgery, the closure top was found to have migrated out of one of the screws at left s1.Prior to the revision, the patient twisted and felt pain.The physician had to wire the construct to hold it together since the set screw backed out.There was a delay of 30 minutes during the revision surgery.This is report one of two for this 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 Key11947596
MDR Text Key254544500
Report Number3012447612-2021-00198
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 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number07.02010.001
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
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