MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF SYRINGE BODY; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	800247
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when surgeon initially started to expand the cage, pressure would build, then the t-handle would click and then all the pressure would release.O-rings were replaced a couple of times and the steps repeated with more sterile saline the result was same.He barely got 1mm of expansion.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: no relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.The material of the syringe pawls is softer than the syringe plunger threads which results in deformation.Conclusion: the plausible root cause is design related.
Event or Problem Description
It was reported that when surgeon initially started to expand the cage, pressure would build, then the t-handle would click and then all the pressure would release.O-rings were replaced a couple of times and the steps repeated with more sterile saline the result was same.He barely got 1mm of expansion.

• Brand Name: ACCULIF SYRINGE BODY
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5435329
• Report Number: 3004024955-2016-00015
• Device Sequence Number: 325166
• Product Code: MAX
• UDI-Device Identifier: 07613327067118
• UDI-Public: 07613327067118
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 01/19/2016

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: 800247
• Device Lot Number: 06121407-029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2016
• Supplement Report FDA Received Date: 05/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1