MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. VENADO CARBONATE APATITE BLOCK; OSSIMEND BONE GRAFT MATERIAL

Catalog Number	4817-T68202
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician used the product past its expiration date.Additional qc testing of reserve samples met acceptance criteria.Seal integrity and sterility of the reserve samples passed.

• Brand Name: VENADO CARBONATE APATITE BLOCK
• Common Device Name: OSSIMEND BONE GRAFT MATERIAL
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 9450487
• Report Number: 2249852-2019-00023
• Device Sequence Number: 11414599
• Product Code: MQV
• UDI-Device Identifier: 00813954021966
• UDI-Public: 00813954021966
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K052812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 4817-T68202
• Device Lot Number: MCCBUN16A3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1