MAUDE Adverse Event Report: NUOSS COLLAGEN; BONE GRAFTING MATERIAL

Model Number	5099100
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional quality control testing of reserve samples is pending.
Event or Problem 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.
Additional Manufacturer Narrative
Additional quality control testing of reserve samples confirmed that the product met acceptance criteria.

• Brand Name: NUOSS COLLAGEN
• Common Device Name: BONE GRAFTING MATERIAL
• MDR Report Key: 11286350
• Report Number: 2249852-2021-00002
• Device Sequence Number: 19926456
• Product Code: NPM
• UDI-Device Identifier: 00614950007493
• UDI-Public: 00614950007493
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K043034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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: No Information
• Device Expiration Date: 01/31/2023
• Device Model Number: 5099100
• Device Catalogue Number: 5099100
• Device Lot Number: BMBU19N2
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 02/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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: 68 YR