MAUDE Adverse Event Report: CENTINEL SPINE, LLC. STALIF C ABO SCREW, 4.0MM DIA X 14MM (TI); INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	ABS1440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient received 3 levels of stalif c-ti devices on (b)(6) 2021.Devices were implanted at c3/4, c5/6, and c6/7.About 2 months after implantation, centinel was made aware of a c6 vertebral collapse between 2 of the stalif c-ti cages.The patient was revised to a c6 corpectomy via explantation of the stalif c-ti cages and screws at c5/6 and c6/7.There was no indication that c3/4 was revised.The revising surgeon believed the collapsed vertebrae was due to patient anatomy; however, the devices could not be ruled out as contributory.There was no indication of a device malfunction.Dhr review for the involved implants did not find any issues during manufacturing which may have caused or contributed.The rate of complaints was determined to be acceptable and within the allowable limits of the risk assessment for the devices.The risk assessment has identified the risks of vertebral collapse with the use of stalif c-ti cages and screws.No device was returned for evaluation.This submission is for 1 device out of 12 devices involved in total.It is unknown which devices were explanted from the patient or remain implanted, thus all devices involved were reported.
Event or Problem Description
A patient received 3 levels of stalif c-ti interbody cages and abo screws at c3/4, c5/6, and c6/7 on (b)(6) 2021.On an unknown date, the patient presented with a collapsed c6 vertebrae identified via lateral x-ray.On (b)(6) 2021, the patient was revised to a c6 corpectomy by removal of 2 of the 3 stalif c-ti cages.

• Brand Name: STALIF C ABO SCREW, 4.0MM DIA X 14MM (TI)
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 11869832
• Report Number: 3007494564-2021-00043
• Device Sequence Number: 3215324
• Product Code: OVE
• UDI-Device Identifier: 00815101029016
• UDI-Public: 00815101029016
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K133200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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: 08/16/2023
• Device Model Number: ABS1440
• Device Lot Number: 2020-0545
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/24/2021
• 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; Disability
• Patient Age: 45 YR