MAUDE Adverse Event Report: STRYKER SPINE-US 11X28X12DEG-11; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48953112
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient that was in pain.Upon post-op x-ray, it was confirmed that the cage had migrated.The patient underwent revision surgery to replace the cage with larger size cage.
Additional Manufacturer Narrative
Labelling review and risk assessment.Visual, dimensional, functional, and materials analysis could not be performed as the device was discarded.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.A cage main body migration/pull out post-operatively was confirmed via correspondence.The migration occurred on l4/l5 posteriorly.There were no reported migration, loosening, or fracture of the supplemental fixation system.There was no patient fall or trauma reported after the surgery.During the primary surgery, the surgeon sized the disc space using a disc shaver, the feel of the shaver was secure, and there were no compression applied after the cage implantation.Based on information received, the root cause of the reported event could not be determined conclusively; however, the plausible root cause could be due to the improper size of cage inserted.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." "effective distraction aids in removal of the superior articular process, decompression of the neuroforamen, preparation of the disc space and insertion of the cage.Particularly in patients with less than ideal bone quality, it might be useful to size the interspace with paddle distractors, reamer distractors, or trials before locking the distraction down through the pedicle screws.Interspace distraction helps provide a sense of restoration of annular tension and helps to avoid pedicle screw pre-loading (which may cause post-operative loosening).".
Event or Problem Description
It was reported that the patient that was in pain.Upon post-op x-ray, it was confirmed that the cage had migrated.The patient underwent revision surgery to replace the cage with larger size cage.

• Brand Name: 11X28X12DEG-11
• 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: 8492739
• Report Number: 3004024955-2019-00009
• Device Sequence Number: 1538291
• Product Code: MAX
• UDI-Device Identifier: 07613327295825
• UDI-Public: 07613327295825
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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: 48953112
• Device Lot Number: EAPM
• 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