MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. RCM6; COLLAGEN PERIODONTAL MEMBRANE

Model Number	5093000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional quality control testing of samples is pending.
Event or Problem Description
It was reported that a patient underwent a surgical extraction with bone graft on (b)(6)2022.The patient was taking z-pazk antibiotics 2 days prior to the surgical procedure.X-rays were takien prior and after the surgical extraction and bone graft.The patient was seen for a follow up 7 days later and still claimed to be sore.A ct scan was take 14 days after the extraction and a sinus infection was noted.Augmention 500 mg was prescribed on (b)(6) 2022 and a z-pack called in on (b)(6) 2022.There was a 3 week delay in procedure noted.The patient was reported to be "doing well" on (b)(6) 2022.
Additional Manufacturer Narrative
Additional quality control testing showed the product was sterile.

• Brand Name: RCM6
• Common Device Name: COLLAGEN PERIODONTAL MEMBRANE
• 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: 14252941
• Report Number: 2249852-2022-00003
• Device Sequence Number: 11873457
• Product Code: NPL
• UDI-Device Identifier: 00614950007325
• UDI-Public: 00614950007325
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K003339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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
• Device Expiration Date: 07/31/2024
• Device Model Number: 5093000
• Device Catalogue Number: 5093000
• Device Lot Number: CMN210604
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female