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

Catalog Number 905103

Device Problems Leak/Splash (1354); Material Integrity Problem (2978); Naturally Worn (2988); No Pressure (2994)

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

Event Date 08/18/2015

Event Type  malfunction  

Event Description

It was reported that; surgeon inserted and steered the cage into anterior column.When placement was confirmed under fluoroscopy, syringe was handed to surgeon and he attempted to expand the implant.He reported that he did not feel pressure building as he made several turns.At first it appeared as if saline was leaking from the syringe body.After the plunger had been fully turned down without pressure we decided to refill saline in syringe.Again no pressure.We then decided to replace the rings on the syringe body and plunger which also did not resolve the problem.We then reinserted the rotator knob and made sure connection was tight, also no help.After case the system was inspected.Saline was leaking from the distal tip of the tubing and pressure was not building.It was noted that the tubing was worn where it contacts the distal portion of the inserter and there was a very small pinhole.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: 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 likely multifactorial in nature, it is unknown during when the damage occurred.

Event Description

It was reported that; surgeon inserted and steered the cage into anterior column.When placement was confirmed under fluoroscopy, syringe was handed to surgeon and he attempted to expand the implant.He reported that he did not feel pressure building as he made several turns.At first it appeared as if saline was leaking from the syringe body.After the plunger had been fully turned down without pressure we decided to refill saline in syringe.Again no pressure.We then decided to replace the rings on the syringe body and plunger which also did not resolve the problem.We then reinserted the rotator knob and made sure connection was tight, also no help.After case the system was inspected.Saline was leaking from the distal tip of the tubing and pressure was not building.It was noted that the tubing was worn where it contacts the distal portion of the inserter and there was a very small pinhole.

• 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 Key: 5083924
• MDR Text Key: 26429107
• Report Number: 3004024955-2015-00073
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 905103
• Device Lot Number: 03041505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2015
• 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