MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. NUOSS COLLAGEN; OSTEOGUIDE ANORGANIC BONE MINERAL WITH COLLAGEN BLOCKS

Model Number	5099250
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the incorrect product was in the box.As per the distributor's representative from the reporting facility, they stated two patients were treated with the mislabeled product, collatene fibrillar collagen rather than nuoss collagen block.A hhe conducted by the distributor and collagen matrix confirmed the health risk is low.
Additional Manufacturer Narrative
Recall 1287163-001-2/11/2022-r has been initiated by the distributor on behalf of the manufacturer.The distributor sent notification to the fda as well as a recall letter to the affected customers on 02/16/2022.The distributor's role includes final packaging and final labeling of the product.Investigation of the event is on-going.
Additional Manufacturer Narrative
Additional quality control testing of reserve samples of the actual device that was implanted in the patients met release criteria.Additional information provided by the distributor on 3/22/2022 stated the following: "i wanted to update you regarding a teleconference that i had with sue huddleston today who is the practicing nurse at dr (b)(6) dds dental office.(b)(6) and i discussed both patients that were treated with collatene fibrillar collagen instead of nuoss collagen block.Sue indicated that both patients were doing very well and that she did not feel that a follow-up augmentation procedure would be required.I had asked her about the patient that was seen after the initial appointment, and she indicated that the follow-up did not identify any adverse findings and that the dentist felt that she was progressing well and that her initial pain post procedure was due to being a slow healer.I asked her if she would like me to guide her through the process of filing a medwatch user report and she declined.She did not indicate whether she would file her own.In summary, ms.Huddleston indicated that both patients were doing very well with out any complications due to the use of the collatene fibrillar product.".

• Brand Name: NUOSS COLLAGEN
• Common Device Name: OSTEOGUIDE ANORGANIC BONE MINERAL WITH COLLAGEN BLOCKS
• 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: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 13806244
• Report Number: 2249852-2022-00001
• Device Sequence Number: 4993876
• Product Code: NPM
• UDI-Device Identifier: 00614950007523
• UDI-Public: 00614950007523
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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?: Yes
• Device Expiration Date: 03/31/2024
• Device Model Number: 5099250
• Device Catalogue Number: 5099250
• Device Lot Number: BMBU21A1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1287163-001-2/11/2022-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown