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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 6972460
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).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
It was reported that the patient underwent arthoplasty due to disc herniation.It was reported that on an unknown date, post-op, patient was having pain due to which patient underwent revision on (b)(6) 2017.The disc was removed and the level was fused.No complications were reported as a result of this event.
 
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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 Key6783837
Report Number1030489-2017-01901
Device Sequence Number16496910
Product Code MJO
UDI-Device Identifier00613994493705
UDI-Public00613994493705
Combination Product (Y/N)N
PMA/510(K) Number
P090029
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source consumer,user facility
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 07/19/2017
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 Catalogue Number6972460
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/19/2017
Initial Report FDA Received Date08/10/2017
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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