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

Model Number	T43105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	07/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Hcps reviews based on donor charts: medical director reviewed the donor chart, and the tro answers to the relevant questions, and he believe that the complaint is unrelated to tissues as received, processed, stored and distributed by medtronic.In compliance with fda guidance on investigation of adverse reactions related to hct/ps, can you please confirm the following for this donor: any additional reports of adverse reactions involving any other organs/tissues recovered from this donor; none.Recovery of the subject donor tissue was performed using a method appropriate to controlling contamination; yes.There were no deviations from established procedures that may have increased the risk of contamination/cross contamination; no deviations from procedures.All supplies and reagents used during the recovery were in compliance with 21cfr1271.210; yes.The recovery was performed within the established time and temperature limits for recovery.Yes.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The information was received from health care provider via a manufacturing representative regarding a patient with spinal stenosis f or posterolateral 2 level lumbar tlif spinal fusion therapy.It was reported that patient had a bad inflammatory response at the site of the graft.Patient had back pain, doctor admitted patient to hospital and removed all the graft.The revision surgery was conducted on (b)(6) 2021.There was no infection suspected, present, or treated.The patient didn't achieve solid fusion.There was no further information reported.

• Brand Name: GRAFTON¿ DBM
• Common Device Name: BONE GRAFTING MATERIAL, HUMAN SOURCE
• MDR Report Key: 12352249
• Report Number: 2246640-2021-00003
• Device Sequence Number: 4417987
• Product Code: NUN
• UDI-Device Identifier: 00643169123151
• UDI-Public: 00643169123151
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2021

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: 05/26/2024
• Device Model Number: T43105
• Device Catalogue Number: T43105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/23/2021
• Date Device Manufactured: 05/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention