MAUDE Adverse Event Report: STRYKER SPINE-US 12MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48955126
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cage backed out post-operatively.The patient underwent revision surgery to replace the cage with alif implant using anterior approach.
Event or Problem Description
It was reported that the cage backed out post-operatively.The patient underwent revision surgery to replace the cage with alif implant using anterior approach.
Additional Manufacturer Narrative
Method: labelling review and risk assessment.Visual, dimensional, functional and materials analysis could not be performed as the device was not returned.Manufacturing record review identified all units met stryker specification.Complaint history review performed, and no similar complaints were identified.It was reported the cage backed out posteriorly at l4/l5; patient underwent a revision surgery on (b)(6) 2019.There was no reported migration, loosening, or fracture of the supplemental fixation system.There was no patient fall or trauma reported.According to the surgical technique statement, "the compression or distraction maneuvers should be performed once all of the blockers are inserted but not final tightened." "choose a cage that is equivalent to the final trial height or final distractor used.The implant sizing is based on the fit and feel of either the final trial or distractor.Implant height should not be oversized.".

• Brand Name: 12MM 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: 8493429
• Report Number: 3004024955-2019-00010
• Device Sequence Number: 11038948
• Product Code: MAX
• UDI-Device Identifier: 07613327118100
• UDI-Public: 07613327118100
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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 Catalogue Number: 48955126
• Device Lot Number: AK8T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 06/05/2019
• 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