MAUDE Adverse Event Report: COLLAGEN MATRIX, INC EASY GRAFT; BONE GRAFTING MATERIAL, SYNTHETIC

Lot Number 21085

Device Problem Osseointegration Problem (3003)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2021

Event Type  malfunction  

Event Description

Based off limited information provided, it was reported that a clinician used easy graft on a patient to graft an extraction site and when they went back in to place the implant, the site was full of granules.The site was cleaned out, process repeated, and the same result occurred.The clinician was told by their distributor representative that they could back into the site after four months to place the implant.

Event Description

It was reported that a clinician used easy graft on a patient during a socket graft for implant placement procedure and the bone did not turn over and resorb.The clinician placed a guidor easy graft classic in the patient on (b)(6) 2021.The first time the product adhered to the tissues.However, for the second time the product was all particulate and large defect.The clinician went back in at about three months both times.The clinician was told by their distributor representative that they could go back into the site after four months to place the implant.The clinician reported that after two guidor failures, mineross was used.

Manufacturer Narrative

Supplemental report submitted due to additional information provided on 06/02/2022.

• Brand Name: EASY GRAFT
• Type of Device: BONE GRAFTING MATERIAL, SYNTHETIC
• 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: 14492220
• MDR Text Key: 295425788
• Report Number: 2249852-2022-00006
• Device Sequence Number: 1
• Product Code: LYC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 21085
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other