MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF PL TUBING SET; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 900301

Device Problems Leak/Splash (1354); Mechanical Problem (1384); Activation Failure (3270)

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

Event Date 11/05/2015

Event Type  malfunction  

Event Description

It was reported that; pt presented to the or with degeneration and foramenal stenosis at the l4/5 level.Dr.Performed a decompression and tlif.He decided to use the 6-9mm cage.The inserter was assembled and the cage was inserted.X-ray confirmed perfect placement.The syringe/plunger was connected, and we started to expand the cage.There was no resistance, and water started leaking around the connection between the syringe and inserter.They syringe was taken off and a green ring was replaced.We put the syringe back on and got the same result.We disconnected the tubing from the handle and inspected it.The red gasket was intact and did not seem damaged.It was reconnected and still was not able to expand the cage.

Manufacturer Narrative

Method: visual inspection; functional inspection; material analysis; device history review; complaint history review; risk assessment.Results: the returned was confirmed to be fractured via visual and functional inspections of the returned device.No relevant manufacturing issues were identified as all released units met stryker specifications.Conclusion: the plausible root cause of the reported event is due to damage to the epoxy joint on the proximal end of the tubing, which is likely to be caused by applying extensive force by the user.

Event Description

It was reported that; pt presented to the or with degeneration and foramenal stenosis at the l4/5 level.Dr.Performed a decompression and tlif.He decided to use the 6-9mm cage.The inserter was assembled and the cage was inserted.X-ray confirmed perfect placement.The syringe/plunger was connected, and we started to expand the cage.There was no resistance, and water started leaking around the connection between the syringe and inserter.They syringe was taken off and a green ring was replaced.We put the syringe back on and got the same result.We disconnected the tubing from the handle and inspected it.The red gasket was intact and did not seem damaged.It was reconnected and still was not able to expand the cage.

• 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: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5260751
• MDR Text Key: 32754836
• Report Number: 3004024955-2015-00101
• 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: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 900301
• Device Lot Number: 04161511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2015
• 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