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

Model Number	CS-MCCBA-200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/04/2022
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 l4-5 transforaminal lumbar interbody fusion (tlif) on (b)(6) 2022.One month after the surgery, patient was at home and felt a sensation of heat throughout his whole body and fainted, striking his head on (b)(6) 2022.Patient's back pain got worse.The patient admitted himself to the emergency department on (b)(6) 2022, complaining of left-sided back pain that is new since the back surgery procedure.Patient describes the back pain "as sharp, radiating down the left leg." the pain is intermittently relieved with percocet.Patient also has experienced weakness/pain in the lateral portion of his left lower extremity.Patient confirmed there have been no further fainting episodes and confirmed there has been no chest pain or palpitations.Emergency department physician confirmed patient did not exhibit focal weaknesses and patient is ambulating with steady gait.Physician attributes syncope episode to likely be orthostatic versus vasovagal.The lumbar site of recent surgery was well-appearing with intact sutures, no tenderness, or erythema.During emergency department visit, patient was administered the following medications: ketorolac (toradol) injection, 30 mg; dexamethasone preservative free (decadron) 10mg/ml injection, 10 mg and iohexol (omnipaque) 350 mg/ml injection 50 ml.Patient was prescribed medication (medrol dosepak 4mg) to treat the lower back pain.Patient was discharged from the emergency department the same day ((b)(6) 2022), with the final emergency department course diagnosis confirmed as back pain.Patient was stable at time of discharge, ambulating with steady gait.No further information on patient status or patient outcome was 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 road; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 16436619
• Report Number: 2249852-2023-00003
• Device Sequence Number: 12612725
• Product Code: MQV
• UDI-Device Identifier: 00813954024127
• UDI-Public: 00813954024127
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: CS-MCCBA-200
• Device Catalogue Number: CS-MCCBA2012
• Device Lot Number: MCCBASAN22A2
• 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: 02/28/2022
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 103 KG