FDA Adverse Event
Injury
Summary report: N
SPINAL IMPLANT
MDR report key: 21654
·
Received May 3, 1995
Report
- Report Number
- MW1005817
- Event Type
- Injury
- Date Received
- May 3, 1995
- Date of Event
- May 14, 1993
- Report Date
- March 16, 1995
- Manufacturer
- UNKNOWN
- Product Code
- JDN
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
SEVERE PAIN; SLEEPLESSNESS; PAIN AND NUMBNESS IN ARMS AND LEGS; KNOT-LIKE FEELING IN BACK WHERE DEVICE IS; CAN'T WALK, SIT OR STAND FOR ANY LENGTH OF TIME; ALWAYS UNCOMFORTABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPINAL IMPLANT | SPINAL IMPLANT | JDN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Disability |