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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 6961460
Medical Device Problem Code Malposition of Device (2616)
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
It was reported that on (b)(6) 2016 (year valid), patient underwent surgery at level c6-7 due to pre-op diagnosis: stenosis at c6-7 along with bone spurs.Two stainless steel metal plates were installed where the bottom plate was parallel with shoulder but the top plate is at an angle of 15 degrees.Due to the malposition of cervical disc device, patient is unable to go more than 4 "pt' sessions due to the increase in pain.Allegedly, patient continues to experience pain in the neck area going down the right shoulder to elbow.
 
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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 Key6773005
Report Number1030489-2017-01870
Device Sequence Number684836
Product Code MJO
UDI-Device Identifier00613994129215
UDI-Public00613994129215
Combination Product (Y/N)N
PMA/510(K) Number
P060018
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 07/10/2017
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? Yes
Operator of Device Health Professional
Device Catalogue Number6961460
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/10/2017
Initial Report FDA Received Date08/08/2017
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 Other;
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