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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US AERO C CAGE 7MM INTERBODY DEVICE, 12DX14W LORDOTIC; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
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STRYKER SPINE-US AERO C CAGE 7MM INTERBODY DEVICE, 12DX14W LORDOTIC; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL Back to Search Results
Catalog Number 48892076
Device Problems Malposition of Device (2616); Migration (4003)
Patient Problems Pain (1994); Tingling (2171)
Event Date 02/07/2019
Event Type  malfunction  
Manufacturer Narrative
Device still in the patient.
 
Event Description
It was reported that the cage started backing out post-operatively.Implant is still in the patient and experienced slight pain and slight tingling in finger.Per the communication with sales rep., x- ray image review which was taken (b)(6) 2019 revealed that cage( pin) had not backed out further.Currently, no revision surgery has been planned.
 
Event Description
It was reported that the cage started backing out post-operatively.Implant is still in the patient and experienced slight pain and slight tingling in finger.Per the communication with sales rep., x- ray image review which was taken (b)(6) 2019 revealed that cage( pin) had not backed out further.Currently, no revision surgery has been planned.
 
Manufacturer Narrative
Method: product history review, complaint history review, labelling review and risk assessment.Dimensional, functional and materials analysis could not be performed as the device remains implanted in patient.Results: the customer reported event of a cage anchor migration post-op was confirmed via x-ray images review.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.No similar complaints for the reported lot number were identified.Conclusion: based on the x-ray image review, the migrated anchor was not fully locked; therefore, the root cause of the reported anchor migration is due to user's deviation of surgical technique.Per surgical technique "step - anchor channel and insertion:.Visually confirm and use lateral fluoroscopic images to verify that the anchors are flush with the jacket.If the anchor is not locked to the jacket, the anchor will protrude approximately 1.25 mm anteriorly.If after removing the implant inserter and anchor tamp, the anchor still appears proud, use the tamp for final placement.Place distal end of tamp against the superior dovetail and tap with mallet to ensure the anchor is fully seated.".
 
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Brand Name
AERO C CAGE 7MM INTERBODY DEVICE, 12DX14W LORDOTIC
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8383672
MDR Text Key138137685
Report Number0009617544-2019-00019
Device Sequence Number1
Product Code ODP
UDI-Device Identifier07613327124668
UDI-Public07613327124668
Combination Product (y/n)N
PMA/PMN Number
K152532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48892076
Device Lot Number161262
Was Device Available for Evaluation? No
Date Manufacturer Received05/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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