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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CENTINEL SPINE, LLC. STALIF C ABO SCREW; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
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CENTINEL SPINE, LLC. STALIF C ABO SCREW; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL Back to Search Results
Model Number ABS1440
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Dysphagia/ Odynophagia (1815); Foreign Body Sensation in Eye (1869); Swollen Lymph Nodes (2093); Burning Sensation (2146); Neck Pain (2433)
Event Date 10/23/2018
Event Type  Injury  
Manufacturer Narrative
The patient has previously submitted a voluntary user medwatch submission (mw5079104).The previous submission indicates the patient suffered a car accident and failed conservative treatment.The patient then received an acdf with centinel's stalif c-ti cage and abo screws.Over a year after the procedure, the patient submitted to the fda indicating they were having pain and other complications.Additional information was not provided to centinel spine during investigation of this submission.On (b)(6) 2019 the patient contacted centinel spine, indicating they had a posterior revision surgery performed at the same level as the stalif c-ti device on (b)(6) 2018.No other additional information regarding the revision was provided.Requests for additional information have not indicated why the revision was required.It has not been confirmed or denied by a medical professional that the stalif c-ti cage or screws contributed to the need for revision.There was no indication that the device has malfunctioned.Based on clinical data of the device as well as other acdf procedures, it's believed the device functioned properly and the level is fully fused.A non-fusion would likely have led to removal of the device which has not been indicated.The patient has also alleged that the device is causing an allergic reaction which has resulted in swelling of the patient's throat and wrists, burning sensation, difficulty breathing, difficulty swallowing, chocking hazards, redness, and other non-specific issues.The patient indicated they are seeing an allergist, but no information has been provided indicating the results of any allergy studies.Contact information for the allergy physician has not been provided.Centinel is reporting this event based on the information provided from the patient.There has been no confirmation available that these complications have been caused or contributed to directly by the device.
 
Event Description
Patient emailed manufacturer directly indicating they received a revision surgery at the level of the stalif c-ti construct on (b)(6) 2018.The patient also indicated they are having side effects they attributed to the stalif c-ti cage and/or stalif c abo screws.The patient has indicated they were instructed by their spine surgeon to seek the care of an allergist.The patient further detailed their symptoms as being: swelling of throat, wrists, burning sensation, difficulty breathing, difficulty swallowing, choking hazard, food going into the airway, redness, and other non-specified issues.
 
Manufacturer Narrative
The patient has not indicated that allergy testing has confirmed nor denied an allergic reaction to the stalif c cage or abo screws implanted within the patient.The patient is still waiting for a diagnosis and indicated additional testing of their condition has been ordered.The patient has not had spine problems prior to their car accident.Patient continues to indicate they are having trouble with swallowing, an abnormal ent exam, swollen lymph nodes, and burning sensation.Patient has indicated they do not have additional information and will contact centinel spine if anything changes with their medical history.
 
Event Description
Patient emailed manufacturer directly indicating they received a revision surgery at the level of the stalif c-ti construct on (b)(6) 2018.The patient also indicated they are having side effects they attributed to the stalif c-ti cage and/or stalif c abo screws.The patient has indicated they were instructed by their spine surgeon to seek the care of an allergist.The patient further detailed their symptoms as being: swelling of throat, wrists, burning sensation, difficulty breathing, difficulty swallowing, choking hazard, food going into the airway, redness, and other non-specified issues.
 
Manufacturer Narrative
The patient submitted an update to report mw5079104 indicating adverse reactions attributed to a foreign body/allergic reaction to the implanted stalif c-ti cage and abo screws.The patient's spine surgeon requested sample devices for allergy testing and referred the patient to an allergy specialists.Information provided by the patient, allergist, and spine surgeon indicate the patient has tested positive on 4 of the tests conducted.Three of the test indicate metal allergies including titanium.The results of the tests were described as minor and of unknown relevance per the provided report.There has been no indication that the results are conclusive enough to advise the patient to have the stalif c-ti cage and abo screws removed.The latest report from the patient's physician indicates they are doing well overall.The root cause of the patient's condition and symptoms is still unknown at this time.If additional information becomes available this report will be updated.
 
Event Description
Patient emailed manufacturer directly indicating they received a revision surgery at the level of the stalif c-ti construct on (b)(6) 2018.The patient also indicated they are having side effects they attributed to the stalif c-ti cage and/or stalif c abo screws.The patient has indicated they were instructed by their spine surgeon to seek the care of an allergist.The patient further detailed their symptoms as being: swelling of throat, wrists, burning sensation, difficulty breathing, difficulty swallowing, choking hazard, food going into the airway, redness, and other non-specified issues.
 
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Brand Name
STALIF C ABO SCREW
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
Manufacturer (Section D)
CENTINEL SPINE, LLC.
900 airport rd, suite 3b
west chester, pa PA 19380
MDR Report Key8866269
MDR Text Key153684221
Report Number3007494564-2019-00005
Device Sequence Number1
Product Code OVE
UDI-Device Identifier00815101028668
UDI-Public00815101028668
Combination Product (y/n)N
PMA/PMN Number
K150053
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 08/20/2019
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
Device Operator Health Professional
Device Expiration Date09/09/2019
Device Model NumberABS1440
Device Lot Number2016-194
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/06/2019
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received08/20/2019
04/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age38 YR
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