FDA Adverse Event Injury Summary report: N

*

MDR report key: 542824 · Received July 22, 2004

Report

Report Number
MW1032737
Event Type
Injury
Date Received
July 22, 2004
Date of Event
May 2, 2004
Report Date
July 21, 2004
Manufacturer
*
Product Code
LZW
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

REPORTER IS A PHYSICIAN AND THE FAMILY MEMBER OF THE PT SEVERELY ADVERSELY AFFECTED BY THE USE OF A SCOLIOMETER. THE PROPER USE BY PEDIATRICIAN OF A SCOLIOMETER, AN FDA PRODUCT, YIELDED A FALSE NEGATIVE TEST FOR SCOLIOSIS AND HAS RESULTED IN THE DEVELOPMENT OF A SEVERE CASE OF ADOLESCENT SCOLIOSIS WHICH WILL REQUIRE EXTENSIVE SURGERY TO ACHIEVE EVEN IMPERFECT CORRECTION, A PROLONGED HOSPITALIZATION, POSSIBLE NEED FOR BLOOD TRANSFUSION, AND PUT THIS PT AT RISK FOR SIGNIFICANT NEUROLOGICAL IMPAIRMENT, LOSS OF PHYSICAL FUNCTIONING AND BACK PAIN. CLEARLY, AN OPPORTUNITY TO AVOID THIS CATASTROPHE WAS MISSED BY THE USE OF THE SCOLIMETER WHICH GAVE A FALSE NEGATIVE SCREEN. REPORTER'S ORTHOPEDIC SURGEON, A WELL KNOWN AUTHORITY IN ADOLESCENT SCOLIOSIS, HAS STATED THAT ORTHOPEDIC SOCIETIES DO NOT SUPPORT THE USE OF SCOLIOMETERS, YET THESE DEVICES ARE USED BY PRIMARY CARE PRACTITIONERS AND PEDIATRICIANS. THE ONLY RELIABLE AND ACCURATE WAY TO ASSESS SCOLIOSIS IS THROUGH RADIOGRAPH AFTER A + BENDING TEST, PER THE ORTHOPEDIST AND REVIEW OF THE LITERATURE. RPTR FEELS SCOLIOMETERS SHOULD BE BANNED FROM USE UNTIL THEY CAN BE SHOWN TO RESULT IN EFFECTIVE PREVENTATIVE SCREENING, WHICH WAS THE EXACT OPPSITE OF WHAT HAPPENED TO THE PT WHO NOW HAS TO TRY TO LIVE WITH THE TRAGIC RESULTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * SCOLIOMETER LZW * * *

Patients

Seq Age Sex Outcome Treatment
1 12 YR Hospitalization| R| S