MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC FLAREHAWK INTERBODY FUSION SYSTEM; LUMBAR INTERVERTEBRAL BODY FUSION DEVICE

Model Number II-1-0447/II-1-0392

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/31/2019

Event Type  malfunction  

Event Description

It was reported that the patient went in for a follow up appointment approximately one week after initial implantation and the surgeon identified that the shim component had migrated posteriorly.It could not be confirmed whether the construct was locked during initial implantation.At this time no revision procedure has been scheduled and the surgeon will continue to monitor the patient.If it is determined at a later date that a revision is required, integrity implants will be notified and a supplemental mdr will be submitted.

• Brand Name: FLAREHAWK INTERBODY FUSION SYSTEM
• Type of Device: LUMBAR INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer (Section G): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer Contact: lauren kamer ; 354 hiatt drive; pam beach gardens, FL 33418 ; 5615293861
• MDR Report Key: 8951494
• MDR Text Key: 195587283
• Report Number: 3012797630-2019-00003
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: II-1-0447/II-1-0392
• Device Catalogue Number: FHPA-CS-00-23-B2/FHPAS20623S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 65 YR