MAUDE Adverse Event Report: BIOCOMPOSITES LTD. STIMULAN RAPID CURE 20CC 620-020; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	620-020
Health Effect - Clinical Code	Test Result (2695)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fda report mw5089948 has been submitted relating to a patient with hyperglycemia with a calcium level of 13.9 (ref range 8.3 -10.) biocomposites ltd have a risk assessment for hypercalcemia related events with the use of stimulan products, risk - 00364 states: "use in patients with hypercalcemia is contraindicated.Risk control measures not possible as use in patients with a pre-existing calcium metabolism disorder is under direction of the operating surgeon.Recommended actions: none required.Additional risks created: no additional risk foreseen.Residual risk: the residual risk of exacerbated symptoms associated with hyperglycaemia requiring intervention is broadly acceptable.Risk/benefit analysis: the residual risk of exacerbated symptoms associated with hypercalemia requiring intervention is outweighed by the clinical benefit of using the device.".
Event or Problem Description
Pt experienced hypercalcemia, with a calcium level of 13.9 (ref range 8.3 - 10.4).Fda safety report id#(b)(4).

• Brand Name: STIMULAN RAPID CURE 20CC 620-020
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): BIOCOMPOSITES LTD.; science park; keele; keele, newcastle under lymme ST5 5 NL; UK ST5 5NL
• MDR Report Key: 9481960
• Report Number: 9617083-2019-00005
• Device Sequence Number: 13527221
• Product Code: MQV
• UDI-Device Identifier: 50601557110416
• UDI-Public: 50601557110416
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: 1065982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 12/17/2019
• Report Date (Section F): 09/20/2019

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: No Information
• Device Expiration Date: 05/31/2022
• Device Model Number: 620-020
• Device Catalogue Number: 620-020
• Device Lot Number: SR190508
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5089948
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other