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

Model Number	48950096
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); Numbness (2415)
Date of Event	10/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician reported that a patient experienced numbness and it was confirmed via x-ray that a tritanium pl cage placed in l4/5 migrated post- operatively.Revision surgery was performed.
Event or Problem Description
Physician reported that a patient experienced numbness and it was confirmed via x-ray that a tritanium pl cage placed in l4/5 migrated post-operatively.Revision surgery was performed.
Additional Manufacturer Narrative
Correction to d.10.'returned to manufacturer on': populated date to 11/04/2019 as previously not sent.Correction to h.4.'manufacturing date': updated from 11/11/2019 to 01/19/2018.Visual inspection: the cage was fully intact with no fractures, deformation, or any other nonconformties present.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: early loosening may result from inadequate initial fixation, latent infection, premature loading of the device or trauma.Late loosening may result from trauma, infection, biological complications or mechanical problems, with the subsequent possibility of bone erosion, or pain.The most common cause for this problem is the insertion of an undersized cage, also inadequate site preparation may also be a factor along with inadequate posterior pedicle screw compression after cage insertion.

• Brand Name: 9MM 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: 9312058
• Report Number: 3004024955-2019-00050
• Device Sequence Number: 14080832
• Product Code: MAX
• UDI-Device Identifier: 07613327117318
• UDI-Public: 07613327117318
• 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): 04/24/2020

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: 01/19/2023
• Device Model Number: 48950096
• Device Catalogue Number: 48950096
• Device Lot Number: E56T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 04/24/2020
• 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