MAUDE Adverse Event Report: MUSCULOSKELETAL TRANSPLANT FOUNDATION (MTF) BIOLOGICS PRIME HD DBM; FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Catalog Number 421025

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Event Description

During the application of putty to the right knee, the applicator broke inside the patient.All visible pieces removed by surgeon.X-rays cleared.No harm to patient.

• Brand Name: PRIME HD DBM
• Type of Device: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): MUSCULOSKELETAL TRANSPLANT FOUNDATION (MTF) BIOLOGICS; 125 may st ste 300; edison NJ 08837
• MDR Report Key: 10173413
• MDR Text Key: 195743477
• Report Number: 10173413
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 421025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8395 DA