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

Catalog Number 48667000

Device Problems Inadequacy of Device Shape and/or Size (1583); Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/01/2019

Event Type  Injury  

Event 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.

Event 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.

Manufacturer Narrative

Visual, dimensional, functional inspection, and material analysis could not be performed as the device was not returned.The event of an anchor l locking plate which disengaged from the cage was confirmed base on x-ray images.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." h3 other text : hospital did not return device.

• Brand Name: ANCHOR L LOCKING PLATE LUMBAR STAND ALONE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8684693
• MDR Text Key: 147563397
• Report Number: 3005525032-2019-00043
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07613252655732
• UDI-Public: 07613252655732
• Combination Product (y/n): N
• PMA/PMN Number: K151726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48667000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention