MAUDE Adverse Event Report: NUOSS COLLAGEN; BONE GRAFTING MATERIAL

Model Number 5099100

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

Additional quality control testing of reserve samples is pending.

Event Description

The customer reported that they had a patient that was presented with pain, redness, and swelling in the area after surgery.Revision included re-entering the surgical site, removing the infected tissue, bone, and bioceramic putty, thoroughly cleaning the area with chlorhexidine gluconate.Placing new bioceramic putty in the tooth access, placing new bone, and closing the site with suture.Patients were placed on an antibiotic and chlorhexidine gluconate regimen 2 days prior to treatment and 5 days following treatment.

Manufacturer Narrative

Additional quality control testing of reserve samples confirmed that the product met acceptance criteria.

• Brand Name: NUOSS COLLAGEN
• Type of Device: BONE GRAFTING MATERIAL
• MDR Report Key: 11286359
• MDR Text Key: 230498511
• Report Number: 2249852-2021-00004
• Device Sequence Number: 1
• Product Code: NPM
• UDI-Device Identifier: 00614950007493
• UDI-Public: 00614950007493
• 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,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2023
• Device Model Number: 5099100
• Device Catalogue Number: 5099100
• Device Lot Number: BMBU19N2
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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): Required Intervention
• Patient Age: 61 YR