MAUDE Adverse Event Report: STRYKER SPINE-US AERO AL LUMBAR CAGE 22 X 28MM, 11MM, 08 DEG.; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION

Model Number	48922218
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Blood Loss (2597)
Date of Event	05/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was confirmed via x-ray that 2 blades fractured on the aero al lumbar cage and the left inferior blade of the cage backed out.Patient underwent revision surgery to replace the cage.The event resulted in a two hour surgical delay, as well as bleeding with medical intervention.
Event or Problem Description
It was confirmed via x-ray that 2 blades fractured on the aero al lumbar cage and the left inferior blade of the cage backed out.Patient underwent revision surgery to replace the cage.The event resulted in a two hour surgical delay, as well as bleeding with medical intervention.
Additional Manufacturer Narrative
Visual inspection: the device was inspected and it's confirmed that the returned anchor was broken and damaged.The device and complaint history records were reviewed, no relevant manufacturing issues or similar complaints were identified.A nonconformance was opened to address this event for which there was new harm.Per the aero al surgical technique.1."with all of the anchors inserted and locked in place, supplemental fixation that has been cleared by the fda for use in the lumbosacral spine (e.G.Pedicle screws or, when performing a single-level fusion, an interspinous process plate) must be used to augment stability of the aero-al construct." 2.The pilot cutter may be used to create channels for the anchors.This step is optional, but is recommended for patients with harder bone quality.[.] using the mallet, tap the pilot cutter gently to penetrate the bone and create a channel.A built-in depth stop limits the depth of the pilot cutter insertion.This event was reviewed by a medical professional who concluded: "the bleeding was likely from the iliac artery or vein not the bone.Generally the anchors break on insertion when the pilot cutter is not used properly.It is unlikely that the blades were fine at time of insertion but failed at 3 months post op as we would not normally expect fusion by 3 months.If that second image (with blades) is intra-op or immediate post-op, then the blades were broken/damage at the time of insertion.All 4 look incorrect to me." the probable root cause of the anchor fracture and disengagement is the patient's hard bone quality which made the disc space hard to prepare as reported in this event and/or pilot cutter was not used properly which may have resulted in the blade breaking during insertion.

• Brand Name: AERO AL LUMBAR CAGE 22 X 28MM, 11MM, 08 DEG.
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9044647
• Report Number: 0009617544-2019-00110
• Device Sequence Number: 2664713
• Product Code: OVD
• UDI-Device Identifier: 07613327067620
• UDI-Public: 07613327067620
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: 09/29/2021
• Device Model Number: 48922218
• Device Catalogue Number: 48922218
• Device Lot Number: 1094592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 06/25/2020
• 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