Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CENTINEL SPINE, LLC. STALIF C FLX 12MM X 5.5MM X 6DEG, 16.5ML CAGE; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CENTINEL SPINE, LLC. STALIF C FLX 12MM X 5.5MM X 6DEG, 16.5ML CAGE; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL Back to Search Results
Model Number SCF126506-16
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
Event Type  Injury  
Manufacturer Narrative
A patient with a 3-level fortos-c plate and variable screws suffered a screw fracture of the two inferior screws in c6.The surgeon believes the screws may have fractured due to subsidence of the stalif c flx implant in c5/6.The patient is not experiencing any symptoms; however, revision has been scheduled for (b)(6) 2021 to preclude any injury.X-ray images provided of the patient confirm the screw fracture.The screw heads appear to be unrestricted by the blocking mechanism.This information led to a determination that the revision is to preclude serious injury thus an mdr is required.The mdr will be due prior to the revision surgery thus an initial and follow up submission will be required for this complaint.No other ous submissions are required.Dhr review of all of the involved implants did not find any manufacturing issues which may have contributed to the complaint.Complaint history found the rate of complaints leading to harm to be an improbable probability of occurrence.This is within the allowable limits of the dfmea.The dfmea was reviewed for both fortos-c and stalif c flx.Screw fracture is an indicated risk which may lead to revision and removal.Subsidence is also indicated within the flx dfmea and this can be due to concentrated forces on the implant resulting in vertebral endplate injury.This may further substantiate the surgeon's indication that the subsidence led to screw fracture due to the forces involved.No devices have been returned for evaluation.Revision is scheduled for (b)(6) 2021, the devices remain implanted at this time.The information from the surgeon and the investigation has determined the screw fracture was possibly caused by the stalif c flx subsidence.There is no clear indication why the cage subsided into c6.The cause for the subsidence is unknown.This led to the overall complaint cause to be unknown based on the likely chain of events being subsidence led to the screw fracture and scheduled revision.This submission is for 1 of 3 devices directly involved in this event.
 
Event Description
Patient received a 3-level acdf c3-6 using stalif c flx cages and fortos-c 3-level 48mm plate with variable self-tapping 16mm screws.At 3 month follow up, the patient's imaging showed that the 2 inferior most screws in the c6 vertebrae.The patient has not exhibited any complications or symptoms.Revision has been scheduled for (b)(6) 2021.The surgeon believes the screw fracture may be caused by subsidence of the c5/6 stalif c flx cage into c6.
 
Manufacturer Narrative
Revision was performed (b)(6) 2021.The broken screw heads were removed, but the surgeon could not implant new screws due to the remainder of the broken screws being within the vertebral body.The inferior 2 screws were not replaced and the procedure was concluded.The surgeon indicated that the implants and plate appeared stable despite the 2 inferior screws unable to be replaced.The surgeon believes the screw fracture may be caused by subsidence of the c5/6 stalif c flx cage into c6.The subsidence appeared to have stabilized according to the surgeon.The blocking mechanism was found in the full locked position during the revision, but the broken screw heads were found proud of the blocking mechanism and plate.The broken screw heads were not returned for evaluation.Engineering evaluation of screws and plate from the same lot was conducted to determine how the screw heads were able to escape the blocking mechanism.The evaluation could not identify a way the screw heads could become proud of the blocking mechanism with the mechanism in the locked position.The condition seen in the patient could not be replicated through the evaluation.Additional device analysis has not changed to outcome of the investigation.The screw fractures were attributed to subsidence of the cage into c6; however, the cause of the subsidence is unknown thus the cause for the event remains unknown.This submission is for 1 of 3 devices directly involved in this event.
 
Event Description
Patient received a 3-level acdf c3-6 using stalif c flx cages and fortos-c 3-level 48mm plate with variable self-tapping 16mm screws.At 3 month follow up, the patient's imaging showed that the 2 inferior most screws in the c6 vertebrae.The patient has not exhibited any complications or symptoms.Revision was performed (b)(6) 2021.The broken screw heads were removed, but the surgeon could not implant new screws due to the remainder of the broken screws being within the vertebral body.The inferior 2 screws were not replaced and the procedure was concluded.The surgeon indicated that the implants and plate appeared stable despite the 2 inferior screws unable to be replaced.The surgeon believes the screw fracture may be caused by subsidence of the c5/6 stalif c flx cage into c6.The subsidence appeared to have stabilized according to the surgeon.The patient was asymptomatic leading up to the revision.The revision went well and the patient is recovery in an acceptable manner after surgery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STALIF C FLX 12MM X 5.5MM X 6DEG, 16.5ML CAGE
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
Manufacturer (Section D)
CENTINEL SPINE, LLC.
900 airport rd, suite 3b
west chester PA 19380
Manufacturer (Section G)
TANGIBLE SOLUTIONS INC.
678 yellow springs-fairfield r
fairborn OH 45324
Manufacturer Contact
jason smith
900 airport rd, suite 3b
west chester, PA 19380
4848878810
MDR Report Key12711811
MDR Text Key278792193
Report Number3007494564-2021-00092
Device Sequence Number1
Product Code OVE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173347
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberSCF126506-16
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
Patient SexMale
-
-