MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. NUOSS CORTICAL GRANULES; ANORGANIC BONE MINERAL

Catalog Number 509-1002

Device Problem Osseointegration Problem (3003)

Patient Problem Failure of Implant (1924)

Event Date 02/24/2020

Event Type  Injury  

Event Description

The clinician reported that he performed a bone grafting treatment on a patient and the bone did not set as intended (it was too soft).The granules were disposed of.There was no medical attention required.

• Brand Name: NUOSS CORTICAL GRANULES
• Type of Device: ANORGANIC BONE MINERAL
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 10569978
• MDR Text Key: 208023372
• Report Number: 2249852-2020-00010
• Device Sequence Number: 1
• Product Code: NPM
• Combination Product (y/n): N
• PMA/PMN Number: K043034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 509-1002
• Device Lot Number: BMTU18B1
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 60 YR