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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR C DIAM.3.5MM SELF TAPPING 14MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
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STRYKER SPINE-US ANCHOR C DIAM.3.5MM SELF TAPPING 14MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL Back to Search Results
Model Number 48325314
Device Problems Break (1069); Material Separation (1562); Malposition of Device (2616)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 04/17/2018
Event Type  malfunction  
Event Description
It was reported that during surgery, an x-ray indicated that the screw advanced beyond the implant.The entire construct (2 screws, 1 cage) was removed and replaced with a cage and a plate.Upon removal the cage came apart.All fragments were retrieved.There was a reported 20 minute surgical delay.No reports of adverse consequences to the patient.
 
Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: the reported event was confirmed based on communication with sales representative.The device was not returned for evaluation as it was kept at the hospital therefore functional, visual and dimensional inspections could not be performed.The lot number of the screw was not provided therefore device history review and complaint history review could not be performed.Conclusion: the root cause of the reported event cannot be established based on information provided and without device being returned.Potential root causes may be driving the black line on the screwdriver beyond the indicated area.Stg indicated that the screw is locked when the gold color and the black line are no longer visible.Stg cautions that diving the black line beyond the indicated area may lead to screw and/ or cage deformation.Screw design has a shoulder that prevents the screw from being inserted too deep if proper surgical technique is followed.Furthermore the inserter has a mechanical stop that prevents the implant from being sunk into the disc space.
 
Event Description
It was reported that during surgery, an x-ray indicated that the screw advanced beyond the implant.The entire construct (2 screws, 1 cage) was removed and replaced with a cage and a plate.Upon removal the cage came apart.All fragments were retrieved.There was a reported 20 minute surgical delay.No reports of adverse consequences to the patient.
 
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Brand Name
ANCHOR C DIAM.3.5MM SELF TAPPING 14MM
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key7493377
MDR Text Key107835058
Report Number3005525032-2018-00033
Device Sequence Number1
Product Code OVE
UDI-Device Identifier04546540679772
UDI-Public(01)04546540679772
Combination Product (y/n)N
PMA/PMN Number
K102606
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number48325314
Device Catalogue Number48325314
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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