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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PRESTIGE CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC
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WARSAW ORTHOPEDICS PRESTIGE CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC Back to Search Results
Model Number 6972450
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Dysphagia/ Odynophagia (1815)
Date of Event 12/02/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Information was received from the manufacturer representative regrading an event which occurred after a c4/5, c5/6 acdf procedure.The device was explanted since it was shifting forward and was causing swallowing issues to the patient.The revision surgery was performed and the cages were explanted.
 
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Brand Name
PRESTIGE CERVICAL DISC SYSTEM
Common Device Name
PROSTHESIS, INTERVERTEBRAL DISC
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
MDR Report Key12148712
Report Number1030489-2021-00912
Device Sequence Number4723387
Product Code MJO
UDI-Device Identifier00613994493712
UDI-Public00613994493712
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P090029
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number6972450
Device Catalogue Number6972450
Device Lot Number0791212W
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/01/2021
Initial Report FDA Received Date07/12/2021
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 Other; Required Intervention;
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