FDA Adverse Event
Injury
Summary report: N
PRESTIGE CERVICAL DISC
MDR report key: 2505701
·
Received March 27, 2012
Report
- Report Number
- 1030489-2012-00364
- Event Type
- Injury
- Date Received
- March 27, 2012
- Date of Event
- June 13, 2011
- Report Date
- March 2, 2012
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- MJO
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PATIENT (B)(4) (ADJACENT LEVEL DISEASE), (B)(4). THIS DEVICE WAS USED DURING AN (B)(4) STUDY. THE APPROVED DEVICE PRODUCT CODE IS MJO, (B)(4). THE DEVICE OR APPLICABLE IMAGING STUDIES WERE NOT 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 THE PATIENT UNDERWENT A SURGERY FOR IMPLANT OF AN ARTIFICIAL CERVICAL DISC AT C6-7. APPROXIMATELY 76 MONTHS POST-OP THE PATIENT UNDERWENT ANOTHER PROCEDURE FOR ADJACENT LEVEL PROBLEMS. THE PATIENT UNDERWENT A FUSION AND REMOVAL OF THE ARTIFICIAL DISC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRESTIGE CERVICAL DISC | MJO | WARSAW ORTHOPEDICS | NA | 115760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR | Required Intervention |