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

Catalog Number 905103

Device Problems Disconnection (1171); Fracture (1260); Cut In Material (2454); Activation Failure (3270)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

It was reported that, inserted a 6-9 tl cage into 3/4 and the cage would not expand.The syringe and plunger were checked and refilled.The cage would not expand again.Disconnected the inserter and left the cage in the space at 6mm.A new tubing was used for the next level.Everything was inspected again on the back table.A 6-9 tl cage was inserted into 4/5 and the cage would not expand.The inserter was disconnected and noticed the green tubing looked worn.Both tubings appeared 'cut' near the cage-tubing connection.Both cages were left in the patient.Neither were expanded.The cages were unable to expand and there was a 15 minute delay each for both levels.

Manufacturer Narrative

Results: no relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.The acculif surgical technique states the intraoperative fracture or breakage of instruments can occur; instruments which have experienced extensive use or extensive force are more susceptible to fracture.Conclusion: the plausible root cause is likely multifactorial in nature.

Event Description

It was reported that, inserted a 6-9 tl cage into 3/4 and the cage would not expand.The syringe and plunger were checked and refilled.The cage would not expand again.Disconnected the inserter and left the cage in the space at 6mm.A new tubing was used for the next level.Everything was inspected again on the back table.A 6-9 tl cage was inserted into 4/5 and the cage would not expand.The inserter was disconnected and noticed the green tubing looked worn.Both tubings appeared 'cut' near the cage-tubing connection.Both cages were left in the patient.Neither were expanded.The cages were unable to expand and there was a 15 minute delay each for both levels.

• 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: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4836401
• MDR Text Key: 18293336
• Report Number: 3004024955-2015-00044
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 905103
• Device Lot Number: 03231517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2015
• 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