MAUDE Adverse Event Report: COLLAGEN MATRIX, INC BIA-GEN BIOACTIVE; MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE

Model Number	CS-MCCBA-400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Myalgia (2238)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint was reported from a clinical site that collagen matrix, inc.Is currently collecting data from.Bia-gen bioactive moldable (strip) was used on patient.Patient had surgery for transforaminal lumbar interbody fusion (tlif) and posterior instrumented fusion for the treatment of high-grade anterolisthesis on (b)(6) 2021.Patient returned for clinical follow-up visit 9 months post surgery on (b)(6) 2023 and reported complete improvement of spine symptoms that she had before the surgery.Patient confirmed she "is happy with the surgical outcomes." however, patient complained of hip pain (worsened by ambulation) and generalized muscle pain over the cervicothoracic midline region (worsened by palpation and sometimes edematous).Patient stated standing for too long and sitting for too long "makes it worse." heat and ibuprofen "make it better." the lumbar spine x-rays showed complete reduction of the l4-5 high-grade anterolisthesis and the l3-l5 hardware is well-positioned with no signs of failutre.Complainant confirmed no further treatment regarding the spine surgery is needed.Patient was referred to physiatry to assess muscle pain and hip pain.There was no further information on patient status provided.

• Brand Name: BIA-GEN BIOACTIVE
• Common Device Name: MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE
• Manufacturer (Section D): COLLAGEN MATRIX, INC; 15 thornton rd; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC; 15 thornton rd; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 16436322
• Report Number: 2249852-2023-00002
• Device Sequence Number: 7326169
• Product Code: MQV
• UDI-Device Identifier: 00813954024134
• UDI-Public: 00813954024134
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K182074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2023

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
• Device Expiration Date: 07/31/2024
• Device Model Number: CS-MCCBA-400
• Device Catalogue Number: CS-MCCBA4025
• Device Lot Number: MCCBASAN21H1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 96 KG