MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL 8-12 MM X 11MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 305008

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

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

Event Date 02/16/2016

Event Type  malfunction  

Event Description

It was reported that the cage only expanded a couple of mm then stopped.As the plunger was turned, it just kept spinning and nothing happened.The green indicator kept popping up and down but only to green.When the surgeon removed the syringe and tried to use another one, the syringe was stuck (could not remove from the inserter).After about ten minutes of manipulation, the syringe was able to be removed.A second syringe was then placed on the inserter and when expanding water was leaking out.The o ring was fine when checked, removed the o ring anyway and replaced with new one, and put the syringe back and same issue.

Manufacturer Narrative

Method: device history review; complaint history review; risk assessment; results: visual and functional tests could not be performed as the implant was not returned and it remains implanted.Intra-op images showing the position of the cage are not available.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the root cause of the reported event is loss of pressure.

Event Description

It was reported that the cage only expanded a couple of mm then stopped.As the plunger was turned, it just kept spinning and nothing happened.The green indicator kept popping up and down but only to green.When the surgeon removed the syringe and tried to use another one, the syringe was stuck (could not remove from the inserter).After about ten minutes of manipulation, the syringe was able to be removed.A second syringe was then placed on the inserter and when expanding water was leaking out.The o ring was fine when checked, removed the o ring anyway and replaced with new one, and put the syringe back and same issue.

• Brand Name: ACCULIF TL 8-12 MM X 11MM X 34 MM X 0 DEG CAGE
• 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: 5490212
• MDR Text Key: 40032567
• Report Number: 3004024955-2016-00028
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07613327068054
• UDI-Public: (01)07613327068054
• 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: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 305008
• Device Lot Number: 04271502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2015
• 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