MAUDE Adverse Event Report: COLLAGEN MATRIX, INC OssiMend Bioactive Moldable; BIOACTIVE MINERAL COLLAGEN COMPOSITE

Model Number	MCCBA1006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Bioactive mineral collagen composite was used on patient for lumbar stenosis/laminectomy procedure on (b)(6) 2022.On (b)(6) 2022, patient returned to the er and reported that he had worsening back pain, leg pain, associated weakness, and was unable to urinate.Patient also reported having trouble standing, walking, and getting dressed the night prior to returning to the er.Intervention surgery was required to treat large hematoma at site of lumbar procedure.There was no additional information provided on patient status or patient outcome.
Additional Manufacturer Narrative
Qc testing was performed at the time of product release and produced results that met all acceptance criteria.

• Brand Name: OssiMend Bioactive Moldable
• Common Device Name: BIOACTIVE MINERAL COLLAGEN COMPOSITE
• 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: 15341391
• Report Number: 2249852-2022-00031
• Device Sequence Number: 4529282
• Product Code: MQV
• UDI-Device Identifier: 00813954022932
• UDI-Public: 00813954022932
• 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
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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 Model Number: MCCBA1006
• Device Catalogue Number: MCCBA1006
• Device Lot Number: MCCBASAN22A2
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 79 KG