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.
[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
Report Number | 1030489-2020-00274 |
MDR Report Key | 9802260 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-03-06 |
Date of Report | 2020-03-06 |
Date Mfgr Received | 2020-02-05 |
Device Manufacturer Date | 2019-07-10 |
Date Added to Maude | 2020-03-06 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | STACIE ZIEMBA |
Manufacturer Street | 1800 PYRAMID PLACE |
Manufacturer City | MEMPHIS TN 38132 |
Manufacturer Country | US |
Manufacturer Postal | 38132 |
Manufacturer Phone | 9013963133 |
Manufacturer G1 | WARSAW ORTHOPEDICS |
Manufacturer Street | 2500 SILVEUS CROSSING |
Manufacturer City | WARSAW IN 46582 |
Manufacturer Country | US |
Manufacturer Postal Code | 46582 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PRESTIGE CERVICAL DISC SYSTEM |
Generic Name | PROSTHESIS, INTERVERTEBRAL DISC |
Product Code | MJO |
Date Received | 2020-03-06 |
Model Number | NA |
Catalog Number | 6972660 |
Lot Number | 0739115W |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | WARSAW ORTHOPEDICS |
Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46582 US 46582 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-03-06 |