MAUDE Adverse Event Report: CENTINEL SPINE, LLC. STALIF MIDLINE ABO SCREW 6 X 25MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	STM6025
Medical Device Problem Codes	Biocompatibility (2886); Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information received has been provided direct from the patient.The patient indicated they received a stalif midline ii-ti alif using a midline ii-ti cage and 3 midline screws on (b)(6) 2019.The fusion failed resulting in a pseudoarthrosis and continued pain.The patient underwent an additional surgery to add posterior fusion with unknown devices on an unknown date.This additional surgery was intended to address the failed fusion.According to the patient's information, the patient and surgeon believe the attempted alif failed because of the peek material used to manufacture the stalif midline ii-ti cage.The hydrophobic properties of the peek material did not allow the bone graft to osteo-integrate with the cage.Additionally the patient believes they have a metal allergy.The patient ordered an implant material panel to test multiple materials for an allergic reaction.As of this submission, the results of that allergy panel are unknown.Dhr review of the cage and screws involved did not find any problems during manufacturing related to this event.Complaint history suggests the rate of both failed fusion/pseudoarthrosis and allergic reaction are very low, and within the allowable limits of the devices risk assessments.The risks associated with pseudoarthrosis and allergic reaction are identified, mitigated, and determined to be acceptable.As of this submission the devices remain implanted thus no evaluation of the devices involved has been performed.If the results of the allergy testing panel are made available at a later date, a follow up submission will be completed.This submission is for 1 of 4 devices involved.
Event or Problem Description
A patient received a stalif midline ii-ti cage and stalif midline screws on (b)(6) 2019.The alif procedure resulted in a failed fusion and continued patient pain.The patient underwent surgical intervention to add posterior fusion on an unknown date.According to the information from the patient, the surgeon informed the patient that the failed fusion may be due to the peek material used to make the cage.The patient also suspects they have an allergy to metals used in the implants.As of this report, the allergy could not be confirmed despite the patient undergoing a implant material allergy panel.

• Brand Name: STALIF MIDLINE ABO SCREW 6 X 25MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 11771870
• Report Number: 3007494564-2021-00028
• Device Sequence Number: 14426645
• Product Code: OVD
• UDI-Device Identifier: 00815101029290
• UDI-Public: 00815101029290
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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 Expiration Date: 01/19/2022
• Device Model Number: STM6025
• Device Lot Number: 2018-876
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 05/04/2021
• 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: 52 YR