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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VANTAGE ANTERIOR FIXATION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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WARSAW ORTHOPEDICS VANTAGE ANTERIOR FIXATION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Back to Search Results
Catalog Number 9330000
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Pre-operative diagnosis: hardware failure procedure performed: lateral corpectomy with vantage plate post op, screw separated from plate.Lock screw unlocked and the plate popped off.As a result of this event revision with new plate and lock screw was performed.
 
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Brand Name
VANTAGE ANTERIOR FIXATION SYSTEM
Common Device Name
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
MDR Report Key9919444
Report Number1030489-2020-00413
Device Sequence Number3296728
Product Code KWQ
UDI-Device Identifier00721902705403
UDI-Public00721902705403
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K023797
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/03/2020
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
Operator of Device Health Professional
Device Catalogue Number9330000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/11/2020
Initial Report FDA Received Date04/03/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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