MAUDE Adverse Event Report: GRAFTON PLUS¿ DBM; BONE GRAFTING MATERIAL, HUMAN SOURCE

Model Number T45010AUS

Device Problem Failure to Osseointegrate (1863)

Patient Problems Inadequate Osseointegration (2646); No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2020

Event Type  malfunction  

Manufacturer Narrative

Device is not marketed in us, however a similar device with product id# t45010, 510(k)#: k043048, udi#: (b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Manufacturing assessment five manufacturing records were reviewed, and no deviations were observed.No nonconformance¿s or roars were observed for the batch a43975-034 and part# t45010aus.Test reports were reviewed (med cleaning of whole donors that will not yield soft tissue, base processing router, bulk tissue grinding router, grafton paste reaction router and paste syringe core packaging router).All tests passed and no deviations or non-conformances were observed.Hcps reviews: in hcps opinion, the adverse event was most likely due to surgical technique.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider via a manufacturer representative regarding a patient with cervical degeneration for spinal fusion therapy at c3-t2.It was reported that some of the paste was removed during the revision surgery, as it appeared that it wasn't fusing to the bone.The product will not be returned.There was no post-op infection, or immunological or inflammatory response.There were no further complications reported regarding the event.

• Brand Name: GRAFTON PLUS¿ DBM
• Type of Device: BONE GRAFTING MATERIAL, HUMAN SOURCE
• MDR Report Key: 10464550
• MDR Text Key: 206558684
• Report Number: 2246640-2020-00004
• Device Sequence Number: 1
• Product Code: NUN
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2022
• Device Model Number: T45010AUS
• Device Catalogue Number: T45010AUS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2020
• 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