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

Catalog Number 905103

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

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

Event Date 11/03/2015

Event Type  malfunction  

Event Description

It was reported that; implant didn't expand and there was a leak in the inserter.

Manufacturer Narrative

Catalog #905103, lot # 07101507.Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Upon visual inspection, tubing set was confirmed to be slightly bent, this could have been caused by applying extensive force by the user.No damage to the tubing set was noticed prior the surgery.Conclusion: the root cause of the tubing set leakage is due to the cut on the distal end of the tube and is likely user related.It is unclear as to when this cut occurred.

Event Description

It was reported that; implant didn't expand and there was a leak in the inserter.

• 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: 5260762
• MDR Text Key: 32769616
• Report Number: 3004024955-2015-00100
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2015

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: 905103
• Device Lot Number: 07101507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2015
• 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