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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C 7 X 12 X 14 X 8DEG. CERVICAL STD ALONE CAGE; INTERVERTEBRAL BODY FUSION DEVICE
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STRYKER SPINE-SWITZERLAND ANCHOR C 7 X 12 X 14 X 8DEG. CERVICAL STD ALONE CAGE; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Catalog Number 6741078
Device Problems Material Separation (1562); Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/18/2014
Event Type  malfunction  
Event Description
It was reported that during surgery, the surgeon used anchor-c cage system (fixation of c4-7).The surgeon inserted the cage in to c4/5, and c5/6.The surgeon inserted the cage into c6/7 using the inserter guide and inserted the self-drill screws.The surgeon removes the guide after inserting the screw, and also tightened the screw.When the surgeon checked the x-ray image, it found that the screw was inserted over the locking groove.Afterwards, when tried to remove the screw, cage (titanium part and peek part) was separated.Therefore the surgeon changed the cage to another size cage.
 
Manufacturer Narrative
Method: device history review and visual inspection.Results: no relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Visual inspection confirmed that the peek and titanium pieces are separated.There is noticeable damage to the peek piece, specifically around the screw insertion holes and where the titanium pieces locks in to the peek pieces.The titanium plate normally attaches to the peek cage in three locations: two slots on either side of the anterior face of the cage and one small hole on the anterior face of the cage between the screw insertion holes.The middle hole of the cage that holds the titanium plate is significantly damaged and would not be able to hold the plate.There is minimal damage to the titanium piece by the screw holes as well.Conclusion: based on the event details and the deformation of the returned cage, the plausible root cause is user related.Specifically the bone screw was inserted too far into the peek cage resulting in deformation and separation from the titanium plate.
 
Event Description
It was reported that during surgery, the surgeon used anchor-c cage system (fixation of c4-7).The surgeon inserted the cage in to c4/5, and c5/6.The surgeon inserted the cage into c6/7 using the inserter guide and inserted the self-drill screws.The surgeon removes the guide after inserting the screw, and also tightened the screw.When the surgeon checked the x-ray image, it found that the screw was inserted over the locking groove.Afterwards, when tried to remove the screw, cage (titanium part and peek part) was separated.Therefore the surgeon changed the cage to another size cage.
 
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Brand Name
ANCHOR C 7 X 12 X 14 X 8DEG. CERVICAL STD ALONE CAGE
Type of Device
INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer (Section D)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
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la chaux-de-fonds 2300
CH  2300
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH   2300
Manufacturer Contact
linford leitch
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key4338617
MDR Text Key5220158
Report Number3005525032-2014-00139
Device Sequence Number1
Product Code OVE
Combination Product (y/n)N
Reporter Country CodeJA
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 11/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6741078
Device Lot NumberB44088
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/18/2014
Initial Date FDA Received12/17/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/12/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/06/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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