LUMBAR EXTENSION MACHINE
Received Nov 21, 2003 · Event occurred Mar 24, 1997
Report 1051095-2003-00001 · MDR key 497035
Device
Generic name
Measuring Exercise Machine
Manufacturer
MedxModel number
MEDX LUMBARCatalog number
LU53
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
52 YR
- Bone Fracture(s)
- Pain
- Other (for use when an appropriate patient code cannot be identified)
- Therapy/non-surgical treatment, additional
- Hospitalization required
Narrative
Description of Event or Problem
PT TREATED FOR WORK RELATED BACK INJURY BEGINNING IN 1996. X-RAY DIAGNOSED AS ACUTE LUMBAR STRAIN. PT PRESCRIBED AND TOOK PLACE 10/96 - 12/96. RE-EXAMINATION IN 1/97 SHOWED HERNIATED DISK IN LOW BACK. STARTED SERIES OF PT SESSIONS USING MED AND LUMBAR 2/97 - 4/97. IN 4/97, PT, WHILE UNDERGOING ISOMETRIC TEST UNDER SUPERVISION BY PT FELT A "POP" AND IMMEDIATE PAIN IN LOW BACK. THERAPIST REMOVED PT FROM LUMBAR MACHINE AND APPLIED ICE, PT TRANSPORTED TO ER. INVESTIGATION INDICATES OSTEOPOROSIS HAD BEEN DIAGNOSED BUT NOT REPORTED. THIS INFO MAY NOT HAVE BEEN AVAILABLE TO PT. FOLLOW-UP X-RAY AND MRI SHOW COMPRESSION FRACTURE. FOLLOW-UP X-RAY SHOWS FRACTURE HEALED.
Remedial action
- Patient Monitoring