MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK 8MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48950086
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent l5/s1 posterior lumbar interbody fusion (plif) surgery in october 2017, which was completed without issue.Upon follow up, the cage was reported to have backed out.On (b)(6) 2018, the patient underwent revision surgery.The cage was put into proper position and compression was added with a screw and rod.
Additional Manufacturer Narrative
The customer reported event was confirmed via x-ray images review and correspondence.Device was not returned.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The root cause cannot be determined conclusively although the surgeon considered the possibility that compression at the time of initial surgery was insufficient.
Event or Problem Description
It was reported that a patient underwent l5/s1 posterior lumbar interbody fusion (plif) surgery in (b)(6) 2017, which was completed without issue.Upon follow up, the cage was reported to have backed out.On (b)(6) 2018, the patient underwent revision surgery.The cage was put into proper position and compression was added with a screw and rod.

• Brand Name: 8MM X 6DEG X 9MM X 23MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• MDR Report Key: 7306672
• Report Number: 3004024955-2018-00007
• Device Sequence Number: 1328504
• Product Code: MAX
• UDI-Device Identifier: 07613327117349
• UDI-Public: (01)07613327117349
• Combination Product (Y/N): N
• PMA/510(K) Number: K160955
• 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): 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48950086
• Device Catalogue Number: 48950086
• Device Lot Number: D58D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention