MAUDE Adverse Event Report: MUSCULOSKELETAL TRANSPLANT FOUNDATION DBX; BONE VOID FILLER

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Unspecified Infection (1930)

Event Date 03/12/2015

Event Type  Injury  

Event Description

The serial number of the dbx is currently unknown.It was reported the patient experienced an infection after being implanted with a zero-p va implant with two screws and demineralized bone matrix (dbx) at level c4-c5 on (b)(6) 2015 for a c5 fracture/partial corpectomy, hardware migration, neck pain and dysphagia.The patient was treated with an unknown antibiotic and the infection cleared up a few weeks later.The implant has not been explanted.The patient visited the emergency room for falling down stairs on three separate occasions, (b)(6) 2015.

Manufacturer Narrative

Due to the lack of confirmed donor and graft serial number information, a review of the suitability and processing batch records could not be performed.All available information was reviewed by the mtf's medical director who indicated the following, "alleged infection after implant of hardware and dbx (b)(4) 2015, but no cultures or other details.No serial numbers, thus impossible to investigate further.Patient apparently recovered well." should mtf receive any additional information regarding this report, it shall be forwarded to the fda.No further investigation can be performed.This event is considered closed.

Event Description

Ther serial number of the dbx is currently unknown.It was reported the patient experienced an infection after being implanted with a zero-p va implant with two screws and demineralized bone matrix (dbx) at level c4-c5 on (b)(6) 2015 for a c5 fracture/partial corpectomy, hardware migration, neck pain and dysphagia.The patient was treated with an unknown antibiotic and the infection cleared up a few weeks later.The implant has not been explanted.The patient visited the emergency room for falling down stairs on three separate occasions, (b)(6) 2015.

• Brand Name: DBX
• Type of Device: BONE VOID FILLER
• Manufacturer (Section D): MUSCULOSKELETAL TRANSPLANT FOUNDATION; 125 may street; edison NJ 08837
• Manufacturer (Section G): MUSCULOSKELETAL TRANSPLANT FOUNDATION; 125 may street; edison NJ 08837
• Manufacturer Contact: mary agostisi ; 125 may street; edison, NJ 08837 ; 7326613160
• MDR Report Key: 5517345
• MDR Text Key: 40908874
• Report Number: 2249062-2016-00001
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

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 Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 03/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2016
• 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
• Treatment: C-ARM
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 109