MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ACCULIF PL 6-9MM X 11MM X 27 MM X 8 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	400006
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient heard a loud popping noise and reported it to dr.(b)(6).Dr.(b)(6) took a scan and realized that the cage had collapsed.
Additional Manufacturer Narrative
Gender: m.Method: device history review; complaint history review; risk assessment.Results: the reported device was confirmed to have collapsed upon review of x-ray images.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Conclusion: failure of the implant could not be confirmed as loss of height can be expected due to the settling of the implant post-operation.
Event or Problem Description
It was reported that the patient heard a loud popping noiseand reported it to (b)(6) took a scan and realized that the cage had collapsed.
Additional Manufacturer Narrative
Patient identifier: (b)(6).Medical records indicated: intact hardware.No evidence of breakage or loosening.It looks like there has been some settling throughout the expandable cage.The settling through the cage is probably the pop that the patient felt.Per x-rays review the implant reduced in height by approximately 1mm.1mm settling is normal per the surgical technique.The implant locks at discreet 1mm increments so it is possible for the implant to settle by 1mm after the surgery if the implant was not fully expanded to the next level.1mm settling does not indicate a failure of the device.In conclusion, the implant performed as intended.
Event or Problem Description
It was reported that the patient heard a loud popping noise and reported it to dr.(b)(6).Dr.(b)(6) took a scan and realized that the cage reduced in height post-op.The patient is asymptomatic.

• Brand Name: ACCULIF PL 6-9MM X 11MM X 27 MM X 8 DEG CAGE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5455533
• Report Number: 3004024955-2016-00017
• Device Sequence Number: 10816359
• Product Code: MAX
• UDI-Device Identifier: 07613327066753
• UDI-Public: (01)07613327066753
• 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
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2018

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: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: 400006
• Device Catalogue Number: 400006
• Device Lot Number: 11061408
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2016
• Supplement Date Received by Manufacturer: Not provided; 02/28/2018
• Initial Report FDA Received Date: 02/23/2016
• Supplement Report FDA Received Date: 05/04/2016; 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 100