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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US AERO AL FIXATION ANCHOR, 30MM, BLUE CARTRIDGE; INTERVERTEBRAL BODY FUSION DEVICE
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STRYKER SPINE-US AERO AL FIXATION ANCHOR, 30MM, BLUE CARTRIDGE; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Catalog Number 48923000
Device Problems Mechanical Problem (1384); Malposition of Device (2616); Material Deformation (2976)
Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2015
Event Type  malfunction  
Event Description
It was reported that; during an alif using aero al two of the anchors were impacted but did not engage bone, rather were inserted and ended up in the disc space between the cage and the end plate.This occurred at l5/s1 with the inferior anchors.Additionally at l3/l4 there was an issue with a blade folding like an accordion upon attempted insertion.During this procedure, two cages were implanted and explanted, two were finally implanted and fixated.Patient is fine after surgery there was not damage to the patient.30 minutes + delay for removal of the original implant that failed.
 
Manufacturer Narrative
No evaluation methods were performed.Device evaluation, device history and complaint history could not be performed as no device was returned.The root cause of the reported event cannot be determined conclusively as no devices and insufficient information was received.
 
Event Description
It was reported that; during an alif using aero al two of the anchors were impacted but did not engage bone, rather were inserted and ended up in the disc space between the cage and the end plate.This occurred at l5/s1 with the inferior anchors.Additionally at l3/l4 there was an issue with a blade folding like an accordion upon attempted insertion.During this procedure, two cages were implanted and explanted, two were finally implanted and fixated.Patient is fine after surgery there was not damage to the patient.30 minutes + delay for removal of the original implant that failed.
 
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Brand Name
AERO AL FIXATION ANCHOR, 30MM, BLUE CARTRIDGE
Type of Device
INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer Contact
christa marrow
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key4851769
MDR Text Key5811078
Report Number3004024955-2015-00050
Device Sequence Number1
Product Code OVD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133328
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number48923000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/19/2015
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
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