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

Catalog Number	T43105JPN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Outcomes to adverse event: infection.Manufacturing assessment results: two manufacturing records were reviewed and no related deviations or non conformances were observed for the batch a39430 and part t43105jpn.Grafton putty test reports were reviewed (final product sterility, endotoxin, moisture analysis, glycerol content, calcium assay, environmental monitoring).All tests passed.Hcp reviews: as per hcp opinion the infection was not caused by the grafton putty as received, processed and distributed by medtronic.Also hcp reviewed the donor chart, and he did not believed that our product caused the patient¿s infection.Donor file & donor eligibility records: the donor charts revealed no additional reports of adverse reactions involving any other organs/tissues recovered from this donor.Recovery of the subject donor tissue was performed using a method appropriate to controlling contamination.There were no deviations from established procedures that may have increased the risk of contamination/cross contamination.All supplies and reagents used during the recovery were in compliance with 21cfr1271.210.The recovery was performed within the established time and temperature limits for recovery.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 or Problem Description
It was reported that the patient underwent posterior cervical fixation at c2-t1 due to cervical spondylosis and the unilateral open-door laminoplasty were performed.In the surgery, 5cc of tissue has been implanted in the patient.Post-op, the patient had infection on same level.Patient underwent revision surgery as a result of this event and the tissue was removed from the infected site.

• Brand Name: GRAFTON DBM
• Common Device Name: BONE GRAFTING MATERIAL, HUMAN SOURCE
• Manufacturer (Section D): MEDTRONIC EATONTOWN; 201 industrial way west; eatontown NJ 07724
• MDR Report Key: 9537273
• Report Number: 2246640-2020-00001
• Device Sequence Number: 11331610
• Product Code: NUN
• UDI-Device Identifier: 00643169123151
• UDI-Public: 00643169123151
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2022
• Device Catalogue Number: T43105JPN
• Device Lot Number: A39430-020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 61 YR