MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE® BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

Model Number P1603M

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

Patient Problem Wound Dehiscence (1154)

Event Date 07/10/2021

Event Type  Injury  

Manufacturer Narrative

Although it is unknown whether the product 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 post market clinical study with clinical patient id: (b)(6) and clinical study name (b)(6) and clinical study id is p16-03 for a spinal fusion therapy.It was reported that the patient had wound exploration surgery and wound revision, irrigation, debridement & closure of wound.Index surgery was (b)(6) 2021.Patient was discharged to home on (b)(6) 2021.Levels involved in additional surgical procedure: non-target/non-lumbar level.Related to surgical construct and/or study procedure plf grafting material related possible posterior fixation related - unlikely interbody fusion related unlikely surgical procedure related possible site assessment: plf grafting material: possible; posterior fixation: unlikely; interbody fusion: unlikely; and surgical procedure: possible relevant patient medical history hypertension hyperlipidemia diabetes agoraphobia, anxiety/panic attacks carpal tunel ercetile dysfunction spondylolisthesis, lumbar radiculopathy, thoracic & lumbar neuritis.

• Brand Name: INFUSE® BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12932176
• MDR Text Key: 286583948
• Report Number: 1030489-2021-01502
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: P1603M
• Device Catalogue Number: P1603M
• Device Lot Number: MDC4314AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Date Device Manufactured: 09/17/2020
• 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): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White