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
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was placing a cage in an l4-5 disc space.After positioning the cage the surgeon attached the syringe and plunger comb and began turning the plunger.Under fluor, he could see the cage raising while the pressure gauge began raising.Once the pressure gauge reached the green to yellow transition point the syringe slowly lost pressure.No fluid was visible from any of the attachment points outside of the wound.It was noticed fluid was leaking into the wound.The syringe was removed and refilled with fluid and the surgeon re attached the syringe and attempted to raise the cage again with the same results.At this point the surgeon attached the rotator to the rotator rod in attempts to check if the cage was still securely attached to the inserter.On a/p fluoro inspection it appeared to the surgeon the cage was raising asymmetric and the leading edge of the cage did not raise.Surgeon proceeded with the surgery dis-attaching the inserter to the cage.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual, dimensional and functional analysis could not be performed as the device was not returned and is still implanted.Conclusion: because the device was not returned for evaluation, the root cause could not be determined conclusively.
Event or Problem Description
It was reported that the surgeon was placing a cage in an l4-5 disc space.After positioning the cage, the surgeon attached the syringe and plunger comb and began turning the plunger.Under fluor, he could see the cage raising while the pressure gauge began raising.Once the pressure gauge reached the green to yellow transition point the syringe slowly lost pressure.No fluid was visible from any of the attachment points outside of the wound.It was noticed fluid was leaking into the wound.The syringe was removed and refilled with fluid and the surgeon re attached the syringe and attempted to raise the cage again with the same results.At this point the surgeon attached the rotator to the rotator rod in attempts to check if the cage was still securely attached to the inserter.On a/p fluoro inspection it appeared to the surgeon the cage was raising asymmetric and the leading edge of the cage did not raise.Surgeon proceeded with the surgery dis-attaching the inserter to the cage.

• Brand Name: ACCULIF TL 6-9 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: 5517417
• Report Number: 3004024955-2016-00034
• Device Sequence Number: 247497
• Product Code: MAX
• UDI-Device Identifier: 07613327068030
• UDI-Public: (01)07613327068030
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2016

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: 305006
• Device Lot Number: 06191506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2016
• Supplement Report FDA Received Date: 05/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1