MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC, PALM BEACH GARDENS, FL FLAREHAWK INTERBODY FUSION SYSTEM; SPLIT SHIM, 9 MM OR 12 MM X 23 MM, 0 DEGREE

Model Number	II-1-0388
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 03mar2022 accelus was informed of a complaint on a flarehawk split shim implant during a one level tlif procedure on (b)(6) 2022.It was reported that during the initial procedure the surgeon did not confirm locking of the implant intraoperatively and as a result the shim migrated postoperatively and was removed via an additional surgery on (b)(6)2022.It was reported that during the original procedure, after deployment the audible click on the inserter was heard and the surgeon was under the impression that the shim was locked.It was reported that the surgeon did not confirm locking via a contralateral oblique fluoroscopic image as is required by the surgical technique manual.Postoperatively, the patient was complaining of pain and postoperative imaging showed that the shim was migrating.Further examination of the intraoperative fluoroscopic imaging confirmed that the shim was not locked in the shell at the time of the initial procedure.The revision procedure was performed without complication.No additional patient harm was reported as a result of this occurrence.

• Brand Name: FLAREHAWK INTERBODY FUSION SYSTEM
• Common Device Name: SPLIT SHIM, 9 MM OR 12 MM X 23 MM, 0 DEGREE
• Manufacturer (Section D): INTEGRITY IMPLANTS INC, PALM BEACH GARDENS, FL; 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: rod atkins ; 354 hiatt drive; palm beach gardens, FL 33418 ; 5615064996
• MDR Report Key: 13871251
• Report Number: 3012797630-2022-00012
• Device Sequence Number: 4692617
• Product Code: MAX
• UDI-Device Identifier: 00818613020731
• UDI-Public: (01)00818613020731(10)SM2221
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: II-1-0388
• Device Catalogue Number: FHPAS20023S
• Device Lot Number: SM2221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART: II-1-0453, LOT: SM2302
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female