MAUDE MDR 960748

MDR report key
960748
Report number
MW5004615
Event key
0
Event type
3
Date of event
2007-02-13
Date received
2007-12-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPINAL AIDNON SURGICAL SPINAL DECOMPRESSIONSPINAL AID CENTERS OF AMERICAJFBNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-12-0501. O; 2. R

Event Narratives#

D

Patient 1

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.