MAUDE Adverse Event Report: REGENX GENATE BLEND CORTICO AND CANCELLOUS; BONE GRAFT

Model Number MIN-CO.5

Device Problem Failure to Osseointegrate (1863)

Patient Problem Failure of Implant (1924)

Event Date 09/22/2023

Event Type  Injury  

Event Description

Bonegraft did not osseointegrate.

• Brand Name: GENATE BLEND CORTICO AND CANCELLOUS
• Type of Device: BONE GRAFT
• Manufacturer (Section D): REGENX; 1034 pearl st; brockton MA 02301
• Manufacturer (Section G): REGENX; 1034 pearl st; brockton MA 02301
• Manufacturer Contact: eileen carpentieri ; 1034 pearl st; brockton, MA 02301
• MDR Report Key: 17976545
• MDR Text Key: 326165595
• Report Number: 1287163-2023-01245
• Device Sequence Number: 1
• Product Code: NPZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MIN-CO.5
• Device Lot Number: FG22110056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose