MAUDE Adverse Event Report: LANX/ZIMMER BIOMET SPINE INC. LANX TECHNIQUE DEVICE BONY MATRIX FUSION DEVICE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Failure of Implant (1924); Paralysis (1997); Stenosis (2263)

Event Date 03/07/2017

Event Type  Injury  

Event Description

On (b)(6) 2008 - bone matrix fusion performed at l4 l5 with bone graft using "lanx technique device." spine failed to fuse and pedicle screws flared.Fusion with diagnosis of progressive paralysis, disc id: (b)(4) (b)(6) 2017.Failed fusion of spine with stenosis and progressive paralysis.I 2018 reported to fda/medwatch to has investigator; honorable (b)(6) j.N.Investigated without conclusion or f/u with "fdtc" enforcement.(b)(6) failure to act remedy medical device suspected for failure or adverse action."(b)(6) president holding president that it is a criminal act for failure of principle surgeon, "clonitian", a life shall be held accountable for failure to act for failed device.= (b)(6) (dr), (b)(6) medical center (b)(6).

• Brand Name: LANX TECHNIQUE DEVICE BONY MATRIX FUSION DEVICE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): LANX/ZIMMER BIOMET SPINE INC.
• MDR Report Key: 13995366
• MDR Text Key: 288876864
• Report Number: MW5108717
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening; Disability; Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White