MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR L LUMBAR STAND ALONE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48665025
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient presented with pain post-operatively, x-rays confirmed the plate disengaged from the cage and one of the implanted screws were too long.Patient was revised on (b)(6) 2019.
Additional Manufacturer Narrative
Visual, dimensional, functional inspection, and material analysis could not be performed as the device was not returned.The x-rays provided confirmed one of the screws implanted initially was too long; however, this was not visible on x-rays taken during the surgery.There were no complications during the initial surgery and, per what was reported, appropriate steps from the surgical technique were followed.The plate was inserted using a plate inserter, the surgeon checked if the plate was securely attached, final position of the plate was confirmed with x-rays, the plate was inserted after all 3 screws were in a desired position, and the screws wholes were prepared with an awl.Patient is not very active and did not experience a fall post- op.This was the surgeon¿s first case with an anchor l.The plausible root cause of the reported event could not be determined conclusively from the information provided.Per anchor l risk file, factors that may have contributed to the plate disengagement: high bmi: anchor l surgical technique (stg) indicates "an overweight or obese patient can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself".Implant not positioned ideally within the disc space.Incorrect implant size selected.Patient pathology.Deformed plate during insertion: stg indicated "minimize the number of plate.Deformations as repetitive deformations may jeopardize the integrity of the plate".Hospital did not return device.
Event or Problem Description
It was reported the patient presented with pain post-operatively, x-rays confirmed the plate disengaged from the cage and one of the implanted screws were too long.Patient was revised on (b)(6) 2019.

• Brand Name: ANCHOR L LUMBAR STAND ALONE
• 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: 8684692
• Report Number: 3005525032-2019-00044
• Device Sequence Number: 3029749
• Product Code: MAX
• UDI-Device Identifier: 07613252602378
• UDI-Public: 07613252602378
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K151726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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: 48665025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 08/01/2019
• 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