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

Catalog Number T44115INT

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

Patient Problems Unspecified Infection (1930); Reaction (2414)

Event Date 03/02/2019

Event Type  Injury  

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.Manufacturing assessment review: five manufacturing records were reviewed and no related deviations or non conformances were observed for the batch (b)(4) and part# t44115int.Grafton crunch test reports were reviewed (base sterility, sterility, endotoxin, moisture analysis, glycerol content, calcium assay).All tests passed and no deviations or non conformances were observed.Hcp reviews: based on the information provided, doctor don¿t believe that the patient¿s outcome was not caused by the tissues implanted, as received, processed, packaged , stored and shipped by us.In other words, nothing within the control of mdt, including suitability determination by proxy through our recovery partner, contributed to any events reported from tissues secured and processed from this donor.Donor file & donor eligibility records: the donor charts revealed-no deviations from sop, supplies were in compliance and recovery was performed in time and temperature limits.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 posterolateral spinal surgery due to spinal fracture at t4, t5 and t6, where the patient had been implanted with tissue along with screws from t3 to t7.The patient was in icu for 10 days and after that the patient was transferred to hospitalization.The patient was treated with "fictriazone" and vancomycin 1 gram every 12 hours during he was in icu.On (b)(6) 2019, the patient turned yellow and water started coming out of the injured site.On (b)(6) 2019, the patient underwent revision surgery where the implanted tissue was removed and doctor washed the injured site.There was no necrosis on the walls, there was no pus, there was a granulomatous reaction on the wall and yellowish liquid.The doctor sent a sample of tissue for the culture results and a ¿gram negative bacteria¿ was found in the result on the wound site.Patient never had fever and also patient¿s immune was not compromised and he was not undergoing chemotherapy.The patient recovered few days later and discharged from hospital.

• 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: 8468481
• MDR Text Key: 140457079
• Report Number: 2246640-2019-00005
• Device Sequence Number: 1
• Product Code: NUN
• UDI-Device Identifier: 00643169134324
• UDI-Public: 00643169134324
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: T44115INT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2018
• 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): Other; Required Intervention
• Patient Age: 26 YR