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 2020-03-28 for PRESTIGE CERVICAL DISC SYSTEM 6972450 manufactured by Warsaw Orthopedics.
[186552624]
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
[186552625]
It was reported that the patient presented with disc herniation at c5-c6; and underwent anterior cervical discectomy with cervical arthroplasty and implantation of motion preserving device at c5-c6. Implantation was uneventful and no known complications were noted immediately after the surgery. On (b)(6) 2020, post-op and after the patient's standard follow-up appointment, the surgeon informed that the patient's radiographs showed the implant to have expulsed anteriorly. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00392 |
| MDR Report Key | 9894002 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-28 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2016-12-05 |
| Date Added to Maude | 2020-03-28 |
| 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 | 2020-03-28 |
| Model Number | NA |
| Catalog Number | 6972450 |
| Lot Number | 0535147W |
| 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 | 2020-03-28 |