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