MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48955106
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a cage that was implanted 4 months dislodged from its original position, requiring revision surgery to remove the interbody.
Event or Problem Description
It was reported that a cage that was implanted 4 months dislodged from its original position, requiring revision surgery to remove the interbody.
Additional Manufacturer Narrative
The customer reported event was confirmed via correspondence.The device was not returned and no further information on revision surgery was available.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The root cause of the reported event cannot be conclusively determined because of insufficient information received.

• Brand Name: 10MM X 6DEG X 11MM X 28MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7423395
• Report Number: 3004024955-2018-00019
• Device Sequence Number: 112518
• Product Code: MAX
• UDI-Device Identifier: 07613327118087
• UDI-Public: (01)07613327118087
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: 48955106
• Device Catalogue Number: 48955106
• Device Lot Number: D244
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 04/11/2018
• 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