MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Model Number 7510800

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

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.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.If information is provided in the future, a supplemental report will be issued.

Event Description

The information was received from health care provider via a manufacture representative regarding infuse part for spinal therapy.It was reported that patient suffered postoperative infection following a surgical procedure.The specific organism of concern is mycobacterium fortuitum.At the request of the division of infectious disease, facility contacted medtronic directly to identify if there may be a reasonable chance the infuse part would have been subject to contamination or whether there have been any reported incidences of infection associated with its use.Additional information received states that original surgical procedure date(b)(6) 2020 and readmission date (b)(6) 2020 for surgical infection of surgical site.Pre-op diagnosis: kyphoscoliosis.Procedure involved: lumbar 5- sacral 1 anterior lumbar interbody fusion, thoracic 10-pelvis posterior spinal fusion instrumentation with apical osteotomy and laminectomy.No complications other than the surgical site infection as reported.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11347398
• MDR Text Key: 232505597
• Report Number: 1030489-2021-00223
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843829
• UDI-Public: 00681490843829
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: 7510800
• Device Catalogue Number: 7510800
• Device Lot Number: M111808AAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2020
• 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; Other
• Patient Weight: 90