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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 5.5X40MM VITALITY SPINAL FIXATION SYSTEM

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ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 5.5X40MM VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 801M5540
Device Problem Fracture (1260)
Patient Problems Foreign Body In Patient (2687); Malunion of Bone (4529)
Event Date 08/18/2021
Event Type  Injury  
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 reports 3012447612-2021-00355 through 3012447612-2021-00357.
 
Event Description
It was reported a revision surgery was performed to address post-op screw breakage and malunion. Prior to the revision, the surgeon thought one screw was broken, but three screws were found to be broken during the revision. The shafts of the three screws were unable to be removed and remain implanted within the patient. No new hardware was added during the revision. This is report one of three for this event.
 
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Brand NameCANNULATED POLYAXIAL SCREW 5.5X40MM
Type of DeviceVITALITY 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 Key12470943
MDR Text Key271376011
Report Number3012447612-2021-00355
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number801M5540
Device Lot NumberT10395
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/14/2021 Patient Sequence Number: 1
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