MAUDE Adverse Event Report: MEDTRONIC EATONTOWN GRAFTON DBM; BONE GRAFTING MATERIAL, HUMAN SOURCE

Catalog Number T43110INT

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Hcps review based on donor records: after reviewing the donor records, and the complaint of the surgeon, the hcps see no objective evidence that the graft was the cause of the patient¿s ¿relapse¿.The fact that there was ¿no post-op infection, or immunological or inflammatory response¿ reinforces their conclusion.Manufacturing assessment: no deviations from established procedures were noted that may have increased the risk of contamination/cross contamination.All supplies and reagents utilized were inspected upon receipt and prior to recovery.The supplies and reagents were stored as per packaging or manufacturer recommendation in a temperature controlled environment.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent laminectomy and posterior arthrodesis at l4-l5.During the surgery, the surgeon placed 10 cc putty into the patient.No cage was used; the surgeon only put screws and rod manufactured by medi implants.No intra-operative complications were reported.Approximately a week after the surgery, reportedly, the patient had a relapse and had low levels of saturation among other symptoms.The patient reported experiencing a rare feeling.The surgeon planned a revision surgery due to this event.On (b)(6) 2019, the revision surgery was performed.When the wound was opened, it was observed that the graft had a black-gray color and had an abnormal appearance.The surgeon then commented that the graft was bad and that the patient's body could have rejected the graft.Hence, everything implanted during the initial surgery was completely explanted.The items that were explanted included the reported graft, the screws and the rod.The patient had to be hospitalized due to this event.There was no post-op infection, or immunological or inflammatory response reported.Patient issue has been reported to be resolved.

• Brand Name: GRAFTON DBM
• Type of Device: BONE GRAFTING MATERIAL, HUMAN SOURCE
• Manufacturer (Section D): MEDTRONIC EATONTOWN; 201 industrial way west; eatontown NJ 07724
• Manufacturer (Section G): MEDTRONIC EATONTOWN; 201 industrial way west; eatontown NJ 07724
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9122085
• MDR Text Key: 162313984
• Report Number: 2246640-2019-00008
• Device Sequence Number: 1
• Product Code: NUN
• UDI-Device Identifier: 00643169965003
• UDI-Public: 00643169965003
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K051188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2022
• Device Catalogue Number: T43110INT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2019
• 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): Hospitalization; Required Intervention