SPINAL AID

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-12-05 for SPINAL AID manufactured by Spinal Aid Centers Of America.

Event Text Entries

[783091] I was injured on the job. I understand the table i was using has been approved by you. The table is a non-surgical spinal decompression table known as spinal aid. I have never rec'd any safety specs or instruction by the founder or employer as to safety precautions putting patients on and taking them off of this table. I am a small person, and was expected to take over this job description after an associate dr left the practice. My height was a concern, and my employer was aware that it was a problem. The table is very wide and high off the ground. This makes it next to impossible for a small person to reach across in order to effectively tighten straps on harness and anchor the pt on the table. Upon removing the pt, it is required to hold the pt's leg up -for me- extended above chest level on tip toes in order to remove leg rest from beneath the pt. In doing so, the weight of the pt's lower body forced my left arm and shoulder crashing down, which resulted in 3 injuries to my shoulder that required surgery. I am currently receiving disability. The surgeon told me that i may require a second surgery. This table is unsafe to operate. My concerns have been reported to company, and the board of chiropractic for review. I see more possible injuries in the future. In my case, i could have easily harmed the pt when his legs dropped, and he could have sustain injuries as he already suffered from lower lumbar problems. I will be happy to give you any additional info needed. Please research this. Thank you. Diagnosis or reason for use: lower lumbar problems.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5004615
MDR Report Key960748
Date Received2007-12-05
Date of Report2007-12-05
Date of Event2007-02-13
Date Added to Maude2007-12-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSPINAL AID
Generic NameNON SURGICAL SPINAL DECOMPRESSION
Product CodeJFB
Date Received2007-12-05
OperatorOTHER
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key933713
ManufacturerSPINAL AID CENTERS OF AMERICA
Manufacturer AddressCLEARWATER FL US


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2007-12-05

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