MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF SYRINGE BODY; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 800247

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Leak/Splash (1354); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2015

Event Type  malfunction  

Event Description

It was reported that; it was a two-level mis tlif.Plan was to use acculif for the interbody at l4/5 and l5/s1; when we got to inserting the cage at l5/s1, the surgeon got the cage in okay.When he went to attach the acculif pressure syringe to the inserter, he started to turn it clockwise to expand the cage until he felt a little bit of pressure, we took an image - the cage had expanded slightly, he continued to turn and about 1 or 2 turns when there was a loud clicking noise and the pressure gauge dropped backed to the starting point.Inserter and syringe were inspected, everything was engaged and no leaking.Surgeon kept turning, pressure gauge started to move back up, started to feel pressure, appeared to be expanding, then the noise happened again and the pressure gauge dropped down.Detached the pressure syringe from inserter and inspected the green washer, didn't find anything to be wrong - decided to replace it anyway.Filled up the syringe with water again, put the plunger back in, reattached it to the inserter.Followed the same steps and the same thing happened again - loud click and the pressure gauge dropped.The cage was slightly expanded at that point.The surgeon turned the plunger and syringe one full turn counterclockwise to make sure the cage settles and, when he did, the cage collapsed back to the starting point.No back up syringe - aborted trying to expand the cage at all.Cage was left implanted unexpanded.Inspected the instrumentation, still malfunctioning, leaking coming from where the port meets the syringe.

Manufacturer Narrative

Cat: 800247, lot#: 06121407-064.Method: device inspection and device history review.Results: the device was confirmed to have deformed peek pawls upon visual inspection.This device deformation likely contributed to the lack of pressure and difficulty expansion during the procedure.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Conclusion: the plausible root cause is design related.

Event Description

It was reported that it was a two-level mis tlif.Plan was to use acculif for the interbody at l4/5 and l5/s1; when we got to inserting the cage at l5/s1, the surgeon got the cage in okay.When he went to attach the acculif pressure syringe to the inserter, he started to turn it clockwise to expand the cage until he felt a little bit of pressure, we took an image - the cage had expanded slightly, he continued to turn and about 1 or 2 turns when there was a loud clicking noise and the pressure gauge dropped backed to the starting point.Inserter and syringe were inspected, everything was engaged and no leaking.Surgeon kept turning, pressure gauge started to move back up, started to feel pressure, appeared to be expanding, then the noise happened again and the pressure gauge dropped down.Detached the pressure syringe from inserter and inspected the green washer, didn't find anything to be wrong - decided to replace it anyway.Filled up the syringe with water again, put the plunger back in, reattached it to the inserter.Followed the same steps and the same thing happened again - loud click and the pressure gauge dropped.The cage was slightly expanded at that point.The surgeon turned the plunger and syringe one full turn counterclockwise to make sure the cage settles and, when he did, the cage collapsed back to the starting point.No back up syringe - aborted trying to expand the cage at all.Cage was left implanted unexpanded.Inspected the instrumentation, still malfunctioning, leaking coming from where the port meets the syringe.

• Brand Name: ACCULIF SYRINGE BODY
• 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 Key: 4685915
• MDR Text Key: 16150122
• Report Number: 3004024955-2015-00033
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 800247
• Device Lot Number: 06121407-064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1