FDA Adverse Event
Injury
Summary report: N
BRYAN CERVICAL DISC SYSTEM
MDR report key: 2549918
·
Received April 26, 2012
Report
- Report Number
- 1030489-2012-00561
- Event Type
- Injury
- Date Received
- April 26, 2012
- Date of Event
- March 18, 2011
- Report Date
- March 18, 2011
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- MJO
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE WAS PART OF THE IDE STUDY PRIOR TO DEVICE APPROVAL. THE APPROVED DEVICE IS PRODUCT CODE MJO, (B)(4). THE DEVICE OR APPLICABLE IMAGING STUDIES HAVE NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT APPROXIMATELY 81 MONTHS POSTOPERATIVELY, THE PATIENT HAD AN EXPLANT OF THE ARTIFICIAL DISC PROSTHESIS AT C5-C6 DUE TO MYELOPATHY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRYAN CERVICAL DISC SYSTEM | MJO | WARSAW ORTHOPEDICS | NA | 221-02345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Required Intervention |