MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-01-28 for PRESTIGE CERVICAL DISC SYSTEM 6971650 manufactured by Warsaw Orthopedics.
[179254434]
Pma/510k: this part is not approved for use in the united states; however a like device catalog #: 6972650, pma #: p090029 and udi #: (b)(4) was cleared in the united states. 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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[179254435]
It was reported as per clinical study that the patient presented with cervical spondylotic myelopathy and cervical spondylotic disc herniation. He underwent cervical disc replacement at c5-c6. Standing x-ray and ct images dated (b)(6) 2019 showed normal results. During the follow-up dated (b)(6) 2019, post-op, x-rays showed subduction of implant on the caudal side. The severity of the adverse event was determined to be non-serious. The reason for this event was determined to be unknown. Patient outcome was reported as unrecovered. The patient will undergo follow-up observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00113 |
| MDR Report Key | 9636011 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2017-10-16 |
| Date Added to Maude | 2020-01-28 |
| 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 |
| Product Code | MJO |
| Date Received | 2020-01-28 |
| Model Number | NA |
| Catalog Number | 6971650 |
| Lot Number | 0601602W |
| 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 | 2020-01-28 |