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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
Catalog Number 6972860
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Neck Pain (2433)
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.
 
Event or Problem Description
Pre-operative diagnosis for this procedure: degenerative disk disease it was reported that the patient underwent cervical disk arthroplasty at c5-c6.On an unknown date, post-op, the patient had arm and neck pain.On (b)(6) 2017, anterior cervical discectomy and fusion was performed to remove the device.No product problem was reported for the implant.
 
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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 Key6939586
Report Number1030489-2017-02171
Device Sequence Number10959421
Product Code MJO
UDI-Device Identifier00613994493637
UDI-Public00613994493637
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
P090029
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/14/2017
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? No
Operator of Device Health Professional
Device Expiration Date03/22/2023
Device Catalogue Number6972860
Device Lot Number0372572W
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/14/2017
Initial Report FDA Received Date10/11/2017
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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