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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF PL TUBING SET; INTERVERTEBRAL BODY FUSION DEVICE
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STRYKER SPINE-US ACCULIF PL TUBING SET; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Catalog Number 900301
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/16/2015
Event Type  malfunction  
Event Description
It was reported that; surgeon tried to expand the cage and saline began leaking out of the syringe.He then switched out the tubing set and noticed that when he put the new tubing onto the inserter and locked into place that there was still a gap.Could not get it tighten further.The surgeon had to remove the pl cage and implant another cage.Surgery delayed by 15 minutes.
 
Manufacturer Narrative
Cat #900301, lot # 05201511.Method: device inspection and device history review.Results: manufacturing records were reviewed for the corresponding lot and all passed test.Two tubing sets were visually inspected.No visual anomalies were identified for the first tubing set.The second tubing set is missing red o-ring near the distal end.Functional inspection was performed and it was confirmed that two tubing sets fully engaged to the inserter.It was confirmed that devices meet the specification on the drawings.Conclusion: two tubing sets were found to be fully functional and no failure mode could be identified.
 
Event Description
It was reported that; surgeon tried to expand the cage and saline began leaking out of the syringe.He then switched out the tubing set and noticed that when he put the new tubing onto the inserter and locked into place that there was still a gap.Could not get it tighten further.The surgeon had to remove the pl cage and implant another cage.Surgery delayed by 15 minutes.
 
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Brand Name
ACCULIF PL 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
irma gamonal
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key5145520
MDR Text Key28479547
Report Number3004024955-2015-00079
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 Followup
Report Date 09/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number900301
Device Lot Number05201511
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/16/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/16/2015
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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