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

Model Number	II-1-0447/II-1-0393
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery because the shim component was not locked into the shell.During the revision surgery the surgeon removed the shim, but the shell component was not removed.Since fusion was occurring through the shell, the surgeon left the shell in the disc space and filled it with additional graft.The explanted shell was not returned to the company for evaluation.

• Brand Name: FLAREHAWK INTERBODY FUSION SYSTEM
• Common Device Name: LUMBAR INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens, fl
• MDR Report Key: 9924264
• Report Number: 3012797630-2020-00003
• Device Sequence Number: 14291631
• Product Code: MAX
• UDI-Device Identifier: 00818613020700
• UDI-Public: (01)00818613020700(10)SM2165/(01)00818613020786(10)SM1981
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

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-1-0447/II-1-0393
• Device Catalogue Number: FHPACS0023B2/FHPAS30623S
• Device Lot Number: SM2165/SM1981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR