MAUDE Adverse Event Report: BIOCOMPOSITES LTD STIMULAN RAPID CURE; BONE VOID FILLER

Model Number	620-005
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	02/05/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The issue was first identified 48 hours post op, it wasn't anticipated but reported that in retrospect after reviewing or notes and finding the amount of tobramycin used, it could have been anticipated.Initially to resolve the issue a femoral dialysis catheter was placed and the patient was transferred to a higher level of care (facility with nephrology service).Surgeon stated that the aki could be related to surgery or sepsis.There is no suggestion that stimulan rapid cure caused or contributed to the patients renal failure - the surgeon was trying to prolong life.The treating physician has no concerns regarding the device.Vancomycin and tobramycin are clinically both known to be nephrotoxic and due to the large quantities used may have contributed to the patient's condition.
Event or Problem Description
Report being submitted to match customers report.20 feb 2018 it was reported by the hospital pharmacist that a patient presented with renal failure 48 hours, post surgery.Surgery - pji, explantation septic left knee.The following antimicrobials were given post and pre surgery: pre-op: 2gm cefazolin ivpb, 1500mg vancomycin ivpb bacitracin irrigation, 2.4gm tobramycin & 8mg vancomycin mixed in 80gm pmma 2gm vancomycin mixed with 5cc, stimulan rapid cure to make beads; 1gm vancomycin in wound bed; post-op: 2gm nafcillin ivpb.On 29 feb 2018 information received regarding the death of the patient, 15 days post event.

• Brand Name: STIMULAN RAPID CURE
• Common Device Name: BONE VOID FILLER
• Manufacturer (Section D): BIOCOMPOSITES LTD; keele science park; keele; staffordshire ST5 5 NL; UK ST5 5NL
• MDR Report Key: 7369050
• Report Number: 9617083-2018-00001
• Device Sequence Number: 37530
• Product Code: MQV
• UDI-Device Identifier: 50601557110270
• UDI-Public: 50601557110270
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K141830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 620-005
• Device Catalogue Number: 620-005
• Device Lot Number: 10/17-R354
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BACITRACIN; CEFAZOLIN; NAFCILLIN; TOBRAMYCIN; VANCOMYCIN
• Outcome Attributed to Adverse Event: Death; Required Intervention