MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL 6-9 MM X 11 MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 305006

Device Problems Collapse (1099); Fluid/Blood Leak (1250); Mechanical Problem (1384); Decrease in Pressure (1490)

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

Event Date 08/17/2016

Event Type  malfunction  

Event Description

It was reported that; the surgeon starting turning the t-handle to expand the cage.The cage lifted some, but then the syringe body psi gauge started to release and pressure was lost.We then took off the syringe body and filled with saline again and processed to retry.As he turned the t-handle again, we noticed no water leaking from anywhere on the syringe, inserter or cage.The cage would start to expand and then it was as if intermittently the pressure would hold and then release while the gauge showed just barely in the yellow section.It did not seem as though we hit the 2000 psi required to release the pressure either.This delayed the case by about 5 minutes.We tried one last time to refill the syringe body and expand the cage; it expanded what seems to look like 9mm, the maximum for this cage.However, surgeon kept feeling like pressure would hold one second and then try and release another, so the confidence of the expansion was questioned.There were no adverse effects to the patient and once surgeon reached what seemed to be full expansion, we disconnected the inserter from the cage and continued on with the case.Returning syringe body and tubing only; cage was implanted.Updated: 2 weeks post op the cage collapse.There is no plan for a revision surgery, and no adverse consequences reported.

Manufacturer Narrative

Method: device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Based on the fatigue testing results, the surgeon must consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc.Which may impact the performance of the intervertebral body fusion device.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G.Substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the device.Sales rep reported that the surgeon was hesitant to provide information regarding patient's lifestyle, operative notes and clinical history.According to instruction for use patient activity level and life style may be contributing factors of possible device failure.Conclusion: failure of the implant could not be confirmed conclusively therefore a plausible root cause could not be identified.

Event Description

It was reported that; the surgeon starting turning the t-handle to expand the cage.The cage lifted some, but then the syringe body psi gauge started to release and pressure was lost.We then took off the syringe body and filled with saline again and processed to retry.As he turned the t-handle again, we noticed no water leaking from anywhere on the syringe, inserter or cage.The cage would start to expand and then it was as if intermittently the pressure would hold and then release while the gauge showed just barely in the yellow section.It did not seem as though we hit the 2000 psi required to release the pressure either.This delayed the case by about 5 minutes.We tried one last time to refill the syringe body and expand the cage; it expanded what seems to look like 9mm, the maximum for this cage.However, surgeon kept feeling like pressure would hold one second and then try and release another, so the confidence of the expansion was questioned.There were no adverse effects to the patient and once surgeon reached what seemed to be full expansion, we disconnected the inserter from the cage and continued on with the case.Returning syringe body and tubing only; cage was implanted.Updated: 2 weeks post op the cage collapse.There is no plan for a revision surgery, and no adverse consequences reported.

• Brand Name: ACCULIF TL 6-9 MM X 11 MM 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: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5951322
• MDR Text Key: 55051900
• Report Number: 3004024955-2016-00081
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 305006
• Device Lot Number: 10201506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2015
• 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