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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO AL LUMBAR CAGE 22 X 28MM, 11MM, 08 DEG.; INTERVERTEBRAL BODY FUSION DEVICE.
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STRYKER SPINE-FRANCE AERO AL LUMBAR CAGE 22 X 28MM, 11MM, 08 DEG.; INTERVERTEBRAL BODY FUSION DEVICE. Back to Search Results
Catalog Number 48922218
Device Problems Break (1069); Difficult to Remove (1528); Sticking (1597); Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2016
Event Type  malfunction  
Event Description
It was reported that during the case the bottom left anchor got stuck in the inserter and would not advance into the bone and deformed significantly.Osteophytes were present and the pilot cutter was used.The cutter tip was visibly damaged.It was incredibly difficult to unthread the inside shaft to remove the inserter from the cage.The damaged anchor was retrieved and the case was completed with 3 anchors implanted.
 
Manufacturer Narrative
Catalog# 48922218.Method: visual inspection; device history review; complaint history review; risk assessment results: the returned device was confirmed to be deformed upon visual inspection.No relevant manufacturing issues were identified as all released units met stryker specifications.Conclusion: the plausible root cause is likely due to the hard bone quality of the patient.
 
Event Description
It was reported that during the case the bottom left anchor got stuck in the inserter and would not advance into the bone and deformed significantly.Osteophytes were present and the pilot cutter was used.The cutter tip was visibly damaged.It was incredibly difficult to unthread the inside shaft to remove the inserter from the cage.The damaged anchor was retrieved and the case was completed with 3 anchors implanted.
 
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Brand Name
AERO AL LUMBAR CAGE 22 X 28MM, 11MM, 08 DEG.
Type of Device
INTERVERTEBRAL BODY FUSION DEVICE.
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR  33610
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR   33610
Manufacturer Contact
rakshya bista
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key5439393
MDR Text Key38821657
Report Number0009617544-2016-00061
Device Sequence Number1
Product Code OVD
UDI-Device Identifier07613327065572
UDI-Public07613327065572
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 health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number48922218
Device Lot Number145766
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/21/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/23/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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