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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 Problems Fracture (1260); Leak/Splash (1354); Cut In Material (2454); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2015
Event Type  malfunction  
Event Description
It was reported that the tubing was cut during surgery by the inserter.
 
Manufacturer Narrative
Device history review; complaint history review; risk assessment device not returned.No relevant manufacturing issues were identified as all released units met stryker specifications.The plausible root cause of the reported event is due to the cut on the distal end of the tube.
 
Event Description
It was reported that the tubing was cut during surgery by the inserter.
 
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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
rakshya bista
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key5360785
MDR Text Key36065464
Report Number3004024955-2016-00006
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 12/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number905103
Device Lot Number07241502
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2015
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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