MAUDE Adverse Event Report: PRESSIO, INC. CONTINUUM ACDF IMPLANT KIT - 18X12MM ANGLED; ACDF IMPLANT SYSTEM

Model Number	PS-01-1812A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a c3-c4 anterior fusion procedure that included the use of an 18mm angled continuum implant with an 8mm interbody cage filled with autograft.Two weeks post op it was identified that the interbody cage and continuum implant had migrated forward resulting in the need for a reoperation.On the x-ray imaging, the surgeon observed that the continuum implant was not flush against the interbody cage which could have allowed the migration of the interbody cage.The patient had a terrible cough due to covid post operatively which could have contributed to the migration of the interbody cage.

• Brand Name: CONTINUUM ACDF IMPLANT KIT - 18X12MM ANGLED
• Common Device Name: ACDF IMPLANT SYSTEM
• Manufacturer (Section D): PRESSIO, INC.; 6584 poplar avenue second floo; memphis TN 38138
• Manufacturer Contact: john white ; 6584 poplar avenue second floor; memphis, TN 38138 ; 8666484665
• MDR Report Key: 18007896
• Report Number: 3027305073-2023-00001
• Device Sequence Number: 7276970
• Product Code: PHQ
• UDI-Device Identifier: 00850039803024
• UDI-Public: 00850039803024
• Combination Product (Y/N): N
• PMA/510(K) Number: K200301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: PS-01-1812A
• Device Catalogue Number: PS-01-1812A
• Device Lot Number: 5008638
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: DEPUY PROTI 360 8MM 15 DEGREES PEEK INTERBODY CAGE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White