MAUDE Adverse Event Report: COLLAGEN MATRIX, INC GIBSON HEALTHCARE BONE GRAFT PLUG; SYNOSS COLLAGEN SYNTHETIC MATERIAL - COLLAGEN BONE GRAFT MATRIX

Catalog Number	5824-413
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional quality control testing of samples is pending.
Event or Problem Description
Customer initially reported the gibson bone graft plug was causing healing issues with "a number of patients." additional, limited information was provided.Customer stated at least five patients experienced healing issues.For patient 4 of 5, the bone graft appeared to quickly swell, appear infected and extrude from the extraction site.A few days after implantation (implant date not provided), patient returned to the office and reported having a "terrible taste and smell." medical intervention was required to remove the graft and clean the extraction site.After the initial intervention, customer reported that some patients had to return to the office "a few times" to remove the graft material that continued to extrude and clean and irrigate the sites.It was not specified how many patients had to return to the office, nor was it specified how many times the patients had to return to the office.Customer stated this caused delayed healing and patient pain.Customer confirmed "patients are fine now." however, there was no information provided on current patient status, other specific patient information, and outcome of event.No further information was provided.
Additional Manufacturer Narrative
Additional quality control testing showed the product met acceptable sterility criteria.

• Brand Name: GIBSON HEALTHCARE BONE GRAFT PLUG
• Common Device Name: SYNOSS COLLAGEN SYNTHETIC MATERIAL - COLLAGEN BONE GRAFT MATRIX
• Manufacturer (Section D): COLLAGEN MATRIX, INC; 15 thornton rd; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC; 15 thornton rd; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 16469510
• Report Number: 2249852-2023-00009
• Device Sequence Number: 5133749
• Product Code: LYC
• UDI-Device Identifier: 00813954024233
• UDI-Public: (01)00813954024233(17)240731(10)SMCPN210601
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K083742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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 Catalogue Number: 5824-413
• Device Lot Number: SMCPN210601
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown