MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. REGENEROSS BONE GRAFT PLUG; SYNTHETIC MINERAL COLLAGEN BONE GRAFT MATRIX

Model Number	RGP1020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subsequent product code for suspect medical device is npm.Product code: npm.Product code name: bone grafting material, animal source.Device class: class ii.Classification panel: 76-dental.C.F.R section: 872.3930 - bone grafting material.Additional quality control testing is pending.
Event or Problem Description
Customer reported the zimvie regeneross bone plug was used on a patient after tooth #6 was extracted on (b)(6) 2024.Patient exhibited inflammation, pain and sweating.Revision surgery performed on (b)(6) 2024 and the zimvie bone plug was extracted during the revision procedure.Bone, prf (platelet rich fibrin) and "a small membrane" (name of membrane not provided) was placed in the extraction site during the revision procedure.Customer confirmed the patient's dental implant placement is delayed.Additional clarification surrounding the event and future dental implant surgery was requested but not provided.No further information provided.
Additional Manufacturer Narrative
Subsequent product code for suspect medical device is npm.Product code: npm.Product code name: bone grafting material, animal source.Device class: class ii.Classification panel: 76-dental.C.F.R section: 872.3930 - bone grafting material.Quality control testing of reserve product met acceptance criteria for visual inspection, ph, and formaldehyde residual content.

• Brand Name: REGENEROSS BONE GRAFT PLUG
• Common Device Name: SYNTHETIC MINERAL COLLAGEN BONE GRAFT MATRIX
• 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: 20128583
• Report Number: 2249852-2024-00023
• Device Sequence Number: 12633100
• Product Code: LYC
• UDI-Device Identifier: 00813954025322
• UDI-Public: (01)00813954025322(17)251130(10)SMCPN220901
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: 11/30/2025
• Device Model Number: RGP1020
• Device Catalogue Number: RGP1020
• Device Lot Number: SMCPN220901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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; Other
• Patient Age: 62 YR
• Patient Sex: Unknown