MAUDE Adverse Event Report: CENTINEL SPINE, LLC. STALIF C ABO SCREW 4.0MM X 13MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	ABS1340
Medical Device Problem Codes	Failure to Osseointegrate (1863); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Neck Pain (2433); Malunion of Bone (4529)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient received a 2-level stalif c flx construct using stalif c flx cages and stalif c abo screws at c4/5 and c5/6 on (b)(6) 2020.The patient developed a pseudoarthrosis (non-union/non-fusion) at both levels.The patient also developed segmental kyphosis, radicular symptoms, and other unspecified complications according to the information communicated from the surgeon.There was no indication of a device malfunction; however, the device subsided slightly at c4/5 which may have caused or contributed to the segmental kyphosis.The patient underwent surgical intervention on (b)(6) 2021 to explant the stalif c flx cages and stalif c abo screws.The devices were successfully removed without complications.The devices were replaced with a cortical ring and anterior plate.Review of the device history records found no problems during manufacturing which may have caused or contributed to this event.Complaint trending was found to be within allowable limits based on the design fmea for these devices.The risks associated with this event are identified, mitigated, and determined to be acceptable.The device was disposed by the hospital and not returned for evaluation.This event involves 8 devices.This is submission 5 of 8.
Event or Problem Description
A patient underwent surgical intervention and removal of a 2-level stalif c flx and stalif c abo screw construct at c4/5 and c5/6 due to pseudoarthrosis (non-union), subsidence, segmental kyphosis, radicular pain, and other unindicated complications.The patient had the stalif c flx construct replaced with a cortical ring and anterior plate.The removal went well and good sagittal balance was restored.There was no indication of a device malfunction.

• Brand Name: STALIF C ABO SCREW 4.0MM X 13MM
• 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: 11271975
• Report Number: 3007494564-2021-00007
• Device Sequence Number: 4607348
• Product Code: OVE
• UDI-Device Identifier: 00815101029009
• UDI-Public: 00815101029009
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K133200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 02/02/2021

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: 10/25/2022
• Device Model Number: ABS1340
• Device Lot Number: 2019-0430
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 02/03/2021
• 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