MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ACTIFUSE; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number	506005078068
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	03/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Study title: post-market clinical performance evaluation of actifuse shape type of study: a retrospective study protocol number: bxu537243 site number: 01001 subject number: us020003 should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
A study was performed in which a patient underwent a spinal surgical procedure with placement of actifuse shape 1-2mm in the posterolateral lumbar region.It was reported the patient was discharged three days after the procedure with no post-operative complications reported.Approximately three and a half months post-op, the patient underwent magnetic resonance imaging which revealed a left facet cyst.Approximately four months after the mri, the patient underwent a surgical procedure to excise the cyst.The following day, the patient was discharged.At the time of this report, the patient outcome was unknown.No additional information is available.
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACTIFUSE
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10380054
• Report Number: 1416980-2020-04797
• Device Sequence Number: 16935915
• Product Code: MQV
• UDI-Device Identifier: 05060050780685
• UDI-Public: (01)05060050780685
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K080736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: 03/31/2021
• Device Catalogue Number: 506005078068
• Device Lot Number: ELW77L053AS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 77