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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. MONOAXIAL SCREW, 6.5MM X 50MM; VITALITY SPINAL FIXATION SYSTEM
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ZIMMER BIOMET SPINE INC. MONOAXIAL SCREW, 6.5MM X 50MM; VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 708M6550
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
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 three of six for the event.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is unrefuted for three vitality monoaxial screws for the failure of inadequate locking resulting in post-operative loosening, allowing the closure tops to migrate.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 set screws 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 three of six for the event.
 
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Brand Name
MONOAXIAL SCREW, 6.5MM X 50MM
Type of Device
VITALITY SPINAL FIXATION SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10677860
MDR Text Key211286065
Report Number3012447612-2020-00600
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K171907
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 Number708M6550
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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