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

Catalog Number 905103

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260); Leak/Splash (1354); Difficult to Remove (1528); Material Integrity Problem (2978)

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

Event Date 09/15/2015

Event Type  malfunction  

Event Description

It was reported that; cage would not expand.We changed the green and red rings and got maybe 1mm height expansion, took an x-ray and went back to expand more and would not expand again.Noticed leaking at the connection site where tubing attaches to the handle of the inserter.Tried another tl set and still same result.Went to remove cage and try different tubing and the inserter detached from cage leaving cage in the inter body space.We were unable to remove cage or reattach inserter at this point.The surgeon was happy with placement.The tubing was loose at the connection to the top (handle) of inserter.We tried to get a snug fit and it would not happen.

Manufacturer Narrative

Catalog# 905103, lot# 04161509.Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: upon visual inspection of the returned device the acculif tl tubing set was confirmed to have 2 holes in the proximal end where tubing attaches to the handle of the inserter.Conclusion: the root cause of the tubing set leakage was likely due to the holes identified on the proximal end of the tubing set.

Event Description

It was reported that; cage would not expand.We changed the green and red rings and got maybe 1mm height expansion, took an x-ray and went back to expand more and would not expand again.Noticed leaking at the connection site where tubing attaches to the handle of the inserter.Tried another tl set and still same result.Went to remove cage and try different tubing and the inserter detached from cage leaving cage in the inter body space.We were unable to remove cage or reattach inserter at this point.The surgeon was happy with placement.The tubing was loose at the connection to the top (handle) of inserter.We tried to get a snug fit and it would not happen.

• 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: 5145582
• MDR Text Key: 28499980
• Report Number: 3004024955-2015-00078
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• 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: 04161509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2015
• 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