PRESTIGE CERVICAL DISC SYSTEM 6972660

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-06 for PRESTIGE CERVICAL DISC SYSTEM 6972660 manufactured by Warsaw Orthopedics.

Event Text Entries

[188474992] Product was not 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.
Patient Sequence No: 1, Text Type: N, H10


[188474993] It was reported that the patient presented with c6-c7 disc herniation; and underwent total disc arthroplasty at c6-c7. Two weeks post-op, it was found that the implant had migrated from its place. Hence, a revision surgery was performed, and the migrated implant was completely explanted. Anterior cervical discectomy and fusion (acdf) was also performed as a result of this event. The patient underwent the discectomy at c6-c7 for an extremely large disk rupture at c6-7 direct to the left side.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2020-00274
MDR Report Key9802260
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-06
Date of Report2020-03-06
Date Mfgr Received2020-02-05
Device Manufacturer Date2019-07-10
Date Added to Maude2020-03-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTACIE ZIEMBA
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1WARSAW ORTHOPEDICS
Manufacturer Street2500 SILVEUS CROSSING
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRESTIGE CERVICAL DISC SYSTEM
Generic NamePROSTHESIS, INTERVERTEBRAL DISC
Product CodeMJO
Date Received2020-03-06
Model NumberNA
Catalog Number6972660
Lot Number0739115W
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerWARSAW ORTHOPEDICS
Manufacturer Address2500 SILVEUS CROSSING WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-06

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