MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL 10-16 MM X 11 MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	305010
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor had the implant attached to the inserter everything was attached correctly; tubing was on the implant, the implant was tapped into place, took pictures, got implant to good spot, took a/p and later x-rays and confirmed the position was good.Went to expand the cage and tried to apply the hydraulic pressure, the gauge went up took picture, as the gauge went up the gauge showed 1,00-1200 psi and went down.No decrease was made by the surgeon.So the surgeon refilled with saline and put the inserter back on the implant and was unable to apply any more pressure.Took a later view of the implant and confirmed it was expanded to its desired height.Once the inserter and pbr was removed the surgeon proceeded with rest of the case.The surgeon then noticed that the cage was expanded however the height of the cage was asymmetrical.The cage was put in for 10mm and the rear of the cage was expanded to a 11/12mm, discrepancy between the nose and the rear, doctor did not want to revise this cage and left implanted.He will observe the patient.
Additional Manufacturer Narrative
Product available to stryker: no.Method: device history review; complaint history review; risk assessment.Results: the event was confirmed via correspondence with the sales rep.X-ray images were not received.The device remains implanted and is not available for evaluation.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: because the device was not returned for evaluation the root cause could not be determined conclusively.However, implanting oversized implant may have caused device to expand asymmetrically.
Event or Problem Description
It was reported that the doctor had the implant attached to the inserter everything was attached correctly; tubing was on the implant, the implant was tapped into place, took pictures, got implant to good spot, took a/p and later x-rays and confirmed the position was good.Went to expand the cage and tried to apply the hydraulic pressure, the gauge went up took picture, as the gauge went up the gauge showed 1,00-1200 psi and went down.No decrease was made by the surgeon.So the surgeon refilled with saline and put the inserter back on the implant and was unable to apply any more pressure.Took a later view of the implant and confirmed it was expanded to its desired height.Once the inserter and pbr was removed the surgeon proceeded with rest of the case.The surgeon then noticed that the cage was expanded however the height of the cage was asymmetrical.The cage was put in for 10mm and the rear of the cage was expanded to a 11/12mm, discrepancy between the nose and the rear, doctor did not want to revise this cage and left implanted.He will observe the patient.

• Brand Name: ACCULIF TL 10-16 MM X 11 MM X 34 MM X 0 DEG CAGE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5552632
• Report Number: 3004024955-2016-00040
• Device Sequence Number: 10878503
• Product Code: MAX
• UDI-Device Identifier: 07613327068061
• UDI-Public: (01)07613327068061
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 305010
• Device Lot Number: 12021405
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2016
• Supplement Report FDA Received Date: 06/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1