MAUDE Adverse Event Report: BIOCOMPOSITES LTD. STIMULAN RAPID CURE; BONE VOID FILLER/ GRAFT EXTENDER

Catalog Number 620-010

Device Problem Use of Device Problem (1670)

Patient Problems Renal Disease, End Stage (2039); Renal Failure (2041)

Event Date 01/25/2014

Event Type  Injury  

Event Description

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.

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.

• Brand Name: STIMULAN RAPID CURE
• Type of Device: BONE VOID FILLER/ GRAFT EXTENDER
• Manufacturer (Section D): BIOCOMPOSITES LTD.; keele, staffordshire ; UK
• Manufacturer Contact: richelle hirst ; keele science park; staffordshire ST5 5-NL ; UK ST5 5NL ; 440178233
• MDR Report Key: 3775739
• MDR Text Key: 4356280
• Report Number: 9617083-2014-00013
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 620-010
• Device Lot Number: 08/13-R192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2014
• Initial Date FDA Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization