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

Model Number II-1-0455/II-1-0412

Device Problem Installation-Related Problem (2965)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/04/2019

Event Type  Injury  

Event Description

It was reported that patient underwent a revision surgery because the shim component had migrated posteriorly.During the revision surgery the surgeon removed the shim, but the shell component was not removed.Since the shell was stable and intervertebral height was being maintained, the surgeon left the shell in the disc space and filled it with additional graft.This shim was returned to the manufacturer and no defects were observed.Post-operative imaging from the original procedure indicated that the shim component was not locked into the shell component as indicated in the surgical technique.

• 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: 8465842
• MDR Text Key: 140346860
• Report Number: 3012797630-2019-00001
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00818613020625
• UDI-Public: (01)00818613020625(10)SM2411/(01)00818613020694(10)SM2257
• 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,health
• Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: II-1-0455/II-1-0412
• Device Catalogue Number: FHTA-CT-00-27-B2/FHTAS30627S
• Device Lot Number: SM2411/SM2257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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; Required Intervention
• Patient Age: 70 YR