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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CENTINEL SPINE, LLC. STALIF MIDLINE ABO SCREW 6 X 35MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

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CENTINEL SPINE, LLC. STALIF MIDLINE ABO SCREW 6 X 35MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR Back to Search Results
Model Number STM6035
Device Problem Malposition of Device (2616)
Patient Problem Pain (1994)
Event Date 07/27/2021
Event Type  Death  
Manufacturer Narrative
Information provided from the reporter indicates that the m flx cage was positioned off of midline.After implantation it was indicated the patient was suffering leg pain due to one of the lateral screws protruding into the foramen.The surgeon decided that revision would be needed to correct the pain and device positioning.It's assumed the patient's condition would have been permanent if it were not for surgical intervention.During the revision procedure on (b)(6) 2021, the patients scar tissue led to uncontrollable bleeding from the iliac vein.The patient expired during the revision procedure due to blood loss.The bleeding began while trying to access the lumbar level and mobilize the vein to allow for the 3rd and final screw to be removed from the cage.Dhr did not find any problems that would have contributed to this complaint.Complaint history indicates this is the 1st instance of an anterior lumbar revision resulting in death.This is also the 1st indication of an m flx cage being off midline and/or a screw protruding into the foramen.The rates of complaints for implant positioning and protrusion out of the vertebral body were determined to be acceptable.No devices were returned for evaluation.This submission is for 1 of 4 devices involved in this event.
 
Event Description
A stalif m flx cage was implanted in the patient on (b)(6) 2021 along with 3 stalif midline abo screws.The cage was implanted off of midline and one of the lateral screws was found to be protruding into the foramen about 1mm.This is believed to have caused the patient radiculopathy and leg pain.The surgeon determined that the cage and screws should be revised to correct the positioning.The revision procedure was performed on (b)(6) 2021.The access to the treated level took approximately 1 hour due to scar tissue formation.Once the level was exposed, the surgeon removed the 1st of 3 screws without any issues.The 2nd screw was removed with some bleeding that was controlled.The patient's iliac vein was across the 3rd screw.The vein had scar tissue adherence and was bleeding.The surgeons attempted to control the bleeding and mobilize the vein to remove the 3rd screw; however, the bleeding became uncontrollable.For approximately 3.5 hours the surgeons tried to control the bleeding from the vein, but the patient expired on the operating table due to blood loss.The patient died on (b)(6) 2021.
 
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Brand Name
STALIF MIDLINE ABO SCREW 6 X 35MM
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
Manufacturer (Section D)
CENTINEL SPINE, LLC.
900 airport rd, suite 3b
west chester PA 19380
Manufacturer (Section G)
INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT
no.9 jingke road, nantun dist.
taichung city, taichung
TW  
Manufacturer Contact
jason smith
900 airport rd, suite 3b
west chester, PA 19380
4848878810
MDR Report Key12337985
MDR Text Key267117518
Report Number3007494564-2021-00069
Device Sequence Number1
Product Code OVD
UDI-Device Identifier00815101029313
UDI-Public00815101029313
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 distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/10/2021
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
Device Operator Health Professional
Device Expiration Date11/20/2023
Device Model NumberSTM6035
Device Catalogue NumberN/A
Device Lot Number2020-0562
Initial Date Manufacturer Received 07/27/2021
Initial Date FDA Received08/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2020
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) Death; Required Intervention;
Patient Age46 YR
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