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

Catalog Number T43103JPN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing assessment review: four manufacturing records were reviewed and no related deviations or non conformances were observed for the batch a38045 and part# t43103jpn.Grafton putty test reports were reviewed (base sterility, final product sterility, endotoxin, moisture analysis, glycerol content, calcium assay, environmental monitoring).All tests passed and no deviations or non conformances were observed.Donor file & donor eligibility records: donor eligibility documents were reviewed and no non-conformance was found.The donor charts revealed-no deviations from sop, supplies were in compliance and recovery was performed in time and temperature limits.Hcps reviews based on donor charts: in their opinion, the infection wasn't caused by tissues as received, processed and distributed by us.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.Although it is unknown if the device 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 oblique lumbar interbody fusion and posterior fixation at l3-l4 due to lumbar canal stenosis.Graft was placed inside the cage; and the cage was implanted at the treated intervertebral disc space.On or around (b)(6) 2019, about two weeks post-op, the patient had a crp rise and fever.Infection was also found at the fixed part between the vertebral bodies.The patient has received medication.Hospitalization was prolonged but the prolongation time was unspecified.Bone union is not complete yet (after two and a half months from operation).The symptoms are now reported to be settling down and the patient issue is getting 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: 8931629
• MDR Text Key: 155639481
• Report Number: 2246640-2019-00007
• Device Sequence Number: 1
• Product Code: NUN
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/26/2019

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: Health Professional
• Device Expiration Date: 04/08/2022
• Device Catalogue Number: T43103JPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other