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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL TUBING SET; INTERVERTEBRAL BODY FUSION DEVICE
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STRYKER SPINE-US ACCULIF TL TUBING SET; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Catalog Number 905103
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/08/2015
Event Type  malfunction  
Event Description
It was reported that; surgeon implanted cage and tried to expand.The saline leaked into the disc space.He removed the cage, changed the tubing and tested the tubing on the bank table with the original cage.The cage expanded with the new tubing, but would not decompress.He then opened a new cage and attached to the new tubing and was able to implant the cage.The surgery was delayed by about 45 minutes.
 
Manufacturer Narrative
(b)(4).Visual inspection; functional inspection; device history review; complaint history review; risk assessment; the peek portion of the tube has two holes near the distal tip.Due to holes, the device cannot hold pressure while attempting to expand the implant.The root cause of the tubing set leakage is likely due to the cut on the distal end of the tube and is user related.
 
Event Description
It was reported that; surgeon implanted cage and tried to expand.The saline leaked into the disc space.He removed the cage, changed the tubing and tested the tubing on the bank table with the original cage.The cage expanded with the new tubing, but would not decompress.He then opened a new cage and attached to the new tubing and was able to implant the cage.The surgery was delayed by about 45 minutes.
 
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Brand Name
ACCULIF TL TUBING SET
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 Key5192823
MDR Text Key30349495
Report Number3004024955-2015-00088
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143616
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 10/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number905103
Device Lot Number04161510
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/08/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2015
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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