STIMULAN RAPID CURE
Received Apr 14, 2014 · Event occurred Jan 25, 2014
Report 9617083-2014-00013 · MDR key 3775739
Device
Generic name
Bone Void Filler/ Graft Extender
Manufacturer
Biocomposites Ltd.Catalog number
620-010
Lot number
08/13-R192
Product problems
- Use of Device Problem
Patient
Not reported
- Renal Disease, End Stage
- Renal Failure
Narrative
Description of Event or Problem
FROM A MAUDE EVENT REPORT RECEIVED AT BIOCOMPOSITES INC ON (B)(4) 2014 FROM THE FDA: VOLUNTARY REPORT NO.: (B)(4) HAD BEEN RECEIVED AT FDA VIA THEIR MEDWATCH PROGRAM. FDA HAD FORWARDED THE DETAILS TO BIOCOMPOSITES INC. FOR REVIEW, AS MAY HAVE BEEN UNAWARE OF THE EVENT.
Additional Manufacturer Narrative
SUSPECTED ROOT CAUSE: SERUM CREATINE (A BLOOD MEASUREMENT) IS AN IMPORTANT INDICATOR OF RENAL HEALTH BECAUSE IT IS AN EASILY MEASURED BYPRODUCT OF MUSCLE METABOLISM THAT IS EXCRETED UNCHANGED BY THE KIDNEYS. A SERUM CREATININE OF 1.2MG/DL (110MCG/L) CAN INDICATE SIGNIFICANT RENAL DISEASE AND SYSTEMIC TOXICITY IN AN ELDERLY FEMALE, AS THE KIDNEY FUNCTION IS DEPLETED. CERTAIN DRUGS CAN SOMETIMES CAUSE ABNORMALLY ELEVATED CREATININE LEVELS. ANTIBIOTICS WERE DELIVERED IV- THERE IS NO LINK ESTABLISHED TO SYSTEMIC LEVELS FROM LOCAL DELIVERY. THE PATIENT'S READING HAD INCREASED FROM 1 - NORMAL TO 1.8 - HIGH. SUSPECTED ROOT CAUSE OF HIGH CREATININE LEVEL IS ASSOCIATED WITH RENAL FAILURE, NOT STIMULAN RAPID CURE, WHICH IS CONTRAINDICATED FOR RENAL COMPROMISED PATIENTS.