MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. PRESERVARIDGE PLUG; SYNOSS COLLAGEN SYNTHETHIC MINERAL - COLLAGEN BONE GRAFT MATRIX

Model Number	PRPREG
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is ongoing.Additional quality control results are pending.The parent mdr is mdr 2249852-2023-00020 for suspect device 1 of 5.This mdr is for suspect device 3 of 5.Please refer to mdr numbers 2249852-2023-00020, 2249852-2023-00022, 2249852-2023-00024 and 2249852-2023-00025 for the other reported suspect devices.No initial reporter information was provided.Complaint was reported to manufacturer by distributor.Reporter information was requested but not provided.Additional information and clarification was requested, including: what device was utilized on what patient, the exact number of patients affected, if there was any surgical delay, information related to the reported event, current patient status, and clarification on product information per patient.No additional information was provided after multiple follow-ups.There are two product codes associated with this device: lyc and npm.Section d2 lists code npm.For product code lyc: product code name: bone grafting material, synthetic.Device class: class ii.Classification panel: 76-dental.C.F.R.Section: 872.3930-bone grafting material.
Event or Problem Description
Limited information was provided.It was reported that "several patients" needed to have the preservaridge plugs removed and redrafted.All patients experienced pain and swelling at the graft site.Multiple item numbers and multiple lot numbers for the event were provided, however it was not specified what specific device was utilized on each patient.Only one event date for this issue.Additional information and clarification was requested, including: the exact number of patients affected, if there was any surgical delay, information related to the reported event, current patient status, and clarification on product information per patient.No additional information was provided after multiple follow-ups.
Additional Manufacturer Narrative
Additional quality control testing of reserve product and product from the same lot returned by the distributor were testing for sterility.The product was proven to be sterile.The parent mdr is mdr 2249852-2023-00020 (and mdr 2249852-2023-00020 supplement 1) for suspect device 1 of 5.This mdr (2249852-2023-00023 and 2249852-2023-00023 supplement 1) is for suspect device 3 of 5.Please refer to mdr numbers 2249852-2023-00020 (and 2249852-2023-00020 supplement 1), 2249852-2023-00022 (and 2249852-2023-00022 supplement 1), 2249852-2023-00024 (and 2249852-2023-00024 supplement 1) and 2249852-2023-00025 (and supplement 2249852-2023-00025 supplement 1) for the other reported suspect devices.No initial reporter information was provided.Complaint was reported to manufacturer by distributor.Reporter information was requested but not provided.Additional information and clarification was requested, including: what device was utilized on what patient, the exact number of patients affected, if there was any surgical delay, information related to the reported event, current patient status, and clarification on product information per patient.No additional information was provided after multiple follow-ups.There are two product codes associated with this device: lyc and npm.Section d2 lists code npm.For product code lyc: product code name: bone grafting material, synthetic, device class: class ii, classification panel: 76-dental, c.F.R.Section: 872.3930-bone grafting material.

• Brand Name: PRESERVARIDGE PLUG
• Common Device Name: SYNOSS COLLAGEN SYNTHETHIC MINERAL - COLLAGEN BONE GRAFT MATRIX
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 18116139
• Report Number: 2249852-2023-00023
• Device Sequence Number: 12664766
• Product Code: NPM
• UDI-Device Identifier: 00813954024400
• UDI-Public: (01)00813954024400(17)251130(10)SMCPN220901
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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: PRPREG
• Device Catalogue Number: PRPREG
• Device Lot Number: SMCPN220901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown