MAUDE Adverse Event Report: CENTINEL SPINE, LLC. STALIF MIDLINE ABO SCREW 6.0MM X 25MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	STM6025
Medical Device Problem Codes	Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient received a 2-level stalif m flx construct on (b)(6) 2020 at l4-l5 and l5-s1.The patient was indicated to be obese with poor bone quality.This patient condition may have contributed to the reported event.During post-operative follow-up, lateral x-ray images found that the stalif m flx cage subsided into the l5 vertebral body.This caused 2 of the 3 stalif midline screws implanted at l4-l5 to back out of the construct.The patient was not experiencing any signs or symptoms including pain.The pain the patient was experiencing pre-operative was gone.The surgeon elected to revise the patient by removing the 2 backed out screws and adding posterior fixation to stabilize the implant.One of the 3 screws and the cage were left implanted in the patient.Review of the device history records did not find any issues during manufacturing that may have caused or contributed to this event.The risk assessment for the involved devices identified, mitigated, and determined the risks associated with this event are acceptable.Trend analysis found the rate of this event is within the limits established in the risk assessment.If additional information becomes available, this report may be updated appropriately.
Event or Problem Description
A patient required a revision surgery on (b)(6) 2020 to remove 2 stalif midline screws which had backed out of the l4-l5 stalif m flx construct due to subsidence of the cage into the l5 vertebrae.The screw back out and subsidence was noted during routine post-operative follow-up on (b)(6) 2020.The surgeon elected to remove the screws due to the aggressive screw back out and location to blood vessels to preclude serious injury.In addition to the screw removal, posterior fixation was added to stabilize the implant.The patient did not present with any signs or symptoms related to the screw back out at the follow-up appointment.

• Brand Name: STALIF MIDLINE ABO SCREW 6.0MM 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
• MDR Report Key: 9729216
• Report Number: 3007494564-2020-00007
• Device Sequence Number: 16679217
• Product Code: OVD
• UDI-Device Identifier: 00815101029290
• UDI-Public: 00815101029290
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 02/19/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: STM6025
• Device Lot Number: 2019-0012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/19/2020
• 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: 54 YR