MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48950106
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that a tritanium pl cage migrated post operatively.The patient underwent revision surgery and the cage was replaced.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records and complaint records were reviewed for lot # de6e, which confirmed no relevant manufacturing issues were identified as all units met stryker specifications and no similar complaints were identified.From the tritanium pl surgical technique: the tritanium pl cages are to be used with supplemental fixation that is intended for use in the lumbosacral spine.If pedicle screws were not inserted earlier in the procedure, insert pedicle screws at this point or other appropriate supplemental fixation.Compression of the pedicle screws or interspinous device may be used to create segmental lordosis of the segment fused.It was reported from the surgeon that "denaturing scoliosis and dish were present, so it took some strength to converge on the withdrawn cage (l3/4 left).There were no issues with instruments or implant.The issue was with the patient's anatomy.Lumbar right convex curve, with dish in l1/2/3 and l4/5.The doctor's opinion is the same.The difficulty of getting a grasp of how well the compression took place through images in es2 could also have been a factor in cage backout." based on the surgeon's comments, the most likely root cause was the patient's difficult anatomy leading to inadequate compression causing the cage to migrate.
Event or Problem Description
It was reported that a tritanium pl cage migrated post operatively.The patient underwent revision surgery and the cage was replaced.

• Brand Name: 10MM 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: 8961788
• Report Number: 3004024955-2019-00036
• Device Sequence Number: 14093889
• Product Code: MAX
• UDI-Device Identifier: 07613327117417
• UDI-Public: 07613327117417
• Combination Product (Y/N): N
• PMA/510(K) Number: K181014
• 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): 11/20/2019

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 Expiration Date: 08/17/2022
• Device Catalogue Number: 48950106
• Device Lot Number: DE6E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 11/20/2019
• 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