MAUDE Adverse Event Report: STRYKER SPINE-US 11MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48950116
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one of the two cages migrated post-operatively.Patient is scheduled for a revision on (b)(6) 2019.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records were reviewed and no manufacturing issues were identified.A complaint history review was conducted and no similar complaints were identified.X rays provided confirmed 1 titanium pl cage migrated post-operatively, revision surgery was performed.No operative notes or medical history provided, no information on the patient, no patient fall or trauma, and it is unknown what the patient's activity level is, what level it was implanted, if the pedicle screws were implanted prior to disc prep, and if bone graft was use.Additionally, from the x ray, it appears that the disc space was not fully level, which may have impeded the implant during initial insertion.The surgical technique states that the compression or distraction maneuvers should be performed once all of the blockers are inserted but not final tightened.In this case, the blockers were final tightened before compression was applied.This may have caused extra stress on the supplemental fixation.As the device was not returned, a definite root cause cannot be determined.Possible contributing factors include disc space prep, patient post op activity, final tightening before compression, lack of bone graft used.H3 other text : device was not returned and therefore could not be evaluated.
Event or Problem Description
It was reported that one of the two cages migrated post-operatively.Patient underwent revision surgery on (b)(6) 2019.

• Brand Name: 11MM X 6DEG X 9MM X 23MM
• 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: 8674331
• Report Number: 3004024955-2019-00016
• Device Sequence Number: 2510755
• Product Code: MAX
• UDI-Device Identifier: 07613327117356
• UDI-Public: 07613327117356
• Combination Product (Y/N): N
• 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): 09/17/2019

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: 48950116
• Device Lot Number: E099
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 09/17/2019
• 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