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

Catalog Number 4817-T68202

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2019

Event Type  Injury  

Event 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
• Type of Device: OSSIMEND BONE GRAFT MATERIAL
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer Contact: gloria zuclich ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 9450487
• MDR Text Key: 170249657
• Report Number: 2249852-2019-00023
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 00813954021966
• UDI-Public: 00813954021966
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 4817-T68202
• Device Lot Number: MCCBUN16A3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1